On September 23, 2020, the Securities and Exchange Commission (SEC) adopted amendments to the shareholder proposal rule: Rule 14a-8 under the Securities Exchange Act of 1934. When addressing the concerns of an employee who is nervous to commute to work, Ms. Burke says, “If you are able to work from home, ask to do so. The Department of Justice Antitrust Division and the Federal Trade Commission’s Bureau of Competition issued another reminder yesterday that the COVID-19 pandemic does not exempt companies from complying with federal antitrust laws. These cases take time to germinate, and the bureau has been working on the assumption that Seila Law wouldn't disrupt its enforcement activities. SAN FRANCISCO—The National Law Journal has named Covington to its “Pro Bono Hot List.” The 2018 special report recognizes 14 firms who “have taken on some of the biggest issues of our time.” The Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a new rule yesterday proposing to revise the Anti-Kickback Statute safe harbor at 42 C.F.R. Mr. Nonaka says, “The [fintech charter case] is important litigation, because many of the companies that could be interested in the ... Fred Levy spoke with Law360 about the 2021 National Defense Authorization Act. Mr. Hutt says the problem with the regulation Boeing is challenging “is its ‘heads-we-win, tails-you-lose’ approach that disadvantages contractors and systematically provides windfalls to the government.” He adds, “This one-sided ... On December 10th, the Antitrust Division of the U.S. Department of Justice announced its first criminal indictment targeting an alleged conspiracy to reduce employee wages. Last Friday (May 31, 2019), FDA hosted a public hearing on “Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds.” The hearing followed FDA’s notice in the Federal Register on April 3, 2019, announcing the public hearing and establishing a public docket to obtain information related to cannabis and cannabis-derived ... June 4, 2019, Global Investigations Review. Beth Brinkmann appeared on Intellectual Property Magazine’s podcast to discuss the U.S. Court of Appeals for the Federal Circuit’s ruling in Arthrex v. Smith & Nephew. Ms. Solomon says, “Whether a payments charter would be less likely to attract a lawsuit depends, at least in part, on the legal theory that the OCC uses to support it. As the New York Times has ... Samantha Clark spoke with Bloomberg about the threat to government contractors over the Huawei ban. Pub. Libbie Canter is quoted in Global Data Review regarding the California Attorney General Xavier Beccera’s revisions to the California Consumer Privacy Act’s (CCPA)  regulations. Pilkington North Am., Inc. v. Mitsui Sumitomo Ins. Antitrust Enforcers Warn Of Continued Action Against Collusive Conduct Impacting Workers In U.S. Labor Markets During Pandemic, Paycheck Protection Program Litigation: Four Takeaways from the First Case, Banks Must Watch Out For Fraud Revelations Amid Pandemic, Judges and lawyers reveal litigation tips for less patent popular courts, Managing COVID-19: More SEC Filing Odds and Ends, Federal Reserve Announces Main Street Lending Program and Other Facilities to Provide Credit to Businesses, States, and Municipalities Impacted by COVID-19, The Coming Wave Of Privacy Actions In The Wake Of COVID-19: Six Things To Know, President Trump Signs Executive Order Formalizing “Team Telecom”, Coronavirus/COVID-19: Checklist for U.S. GAO Testimony Before Congress Regarding Emerging Opportunities, Challenges, And Implications for Policy and Research with Artificial Intelligence, 2018 End-of-Year Summary of FDA Advertising and Promotion Enforcement Activity, Ireland joins Covington's Africa practice, U.S. Sanctions Venezuela’s Oil Sector by Adding PdVSA to the SDN List; OFAC Issues General Licenses Temporarily Authorizing Certain Activities by U.S. how is human labor in the spotlight? Lee Tiedrich's comments from the U.S.-China AI Tech Summit are highlighted in this Law360 article providing a roundup of the top corporate news stories from the past week. Government Contracts The firm was also recognized as a finalist for the White Collar Department of the Year and “honorable mention” for general Litigation Department of the Year. The new rule applies to countervailing duty (“CVD”) investigations or administrative reviews initiated on or after April 6, 2020. Mr. Veroneau says, “While the agreement includes much of ... Last Friday (November 2, 2018), FDA announced the availability of its final guidance, "Nutrition and Supplement Facts Labels: Questions and Answers Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals: Guidance for Industry." Bloomberg Law highlighted Covington's Global Problem Solving team and the efforts of the lawyers who make the capability possible. “With Brexit, we saw the Irish office would be of growing importance. “I think this could make a big difference in how firms advise clients on FARA compliance because, up until now, we’ve all had to do a great deal of reading the tea leaves rather than having actual legal precedents to look ... Witney Schneidman appeared on CNBC Africa to discuss President Ramaphosa's first 100 days in office and provide a look ahead at what is to come for South Africa. I do think this is an area where FDA has primary jurisdiction, and the courts should allow at least the questions of the legality of CBD or hemp extracts to be determined ... Next week marks the four-year anniversary of the Supreme Court’s landmark False Claims Act (“FCA”) decision in Universal Health Services, Inc. v. Escobar, 136 S. Ct. 1989 (2016). The Hill has named Covington’s Holly Fechner, Muftiah McCartin, and Bill Wichterman to its annual “Top Lobbyists” list. Ms. Luo says the prospect of potentially lengthy reviews may prompt Chinese companies to stay away from foreign products and services. In Managing IP, Gary Rubman offered litigation tips and advice to lawyers tasked with educating judges in patent cases in less patent-popular courts. The Trump Administration has released the much-anticipated executive order entitled “Lowering Drug Prices by Putting America First” (commonly referred to as the “Most-Favored-Nation” or “MFN” executive order). Releases Final List of Tariffs on $200 Billion in Chinese Imports, Foreign lobbying overhaul loses steam in Congress, District Court Dismisses Major Part of FTC Deceptive Advertising Case, How DOD Plans To Change Commercial Item Contracting, Former FTC Commissioner McSweeny Joins Covington, Former FTC Commissioner, Obama Admin. According to Mr. Guzy, if the EPA finalizes an emissions rule along the lines of what it proposed, legal challenges will likely target the agency’s basis for departing from the previous ... Gary Guzy spoke with the Washington Post about California’s negotiations with the Administration over vehicle fuel-efficiency standards. Reg. That said, while we may not have all of the answers, we are able to share some insights from the CFIUS front lines regarding how the challenges presented by the COVID-19 pandemic ... Thomas Brugato is quoted in Bloomberg Law regarding the EPA’s increased enforcement measures against products making unproven antiviral or disinfectant claims in light of the coronavirus pandemic. Earlier today, President Donald Trump signed into law the Foreign Investment Risk Review Modernization Act (FIRRMA) as part of the John S. McCain National Defense Authorization Act. It was business as usual for FCPA enforcement in 2018. This dual trend is interesting — I think it speaks to the overall evolution of the ... WASHINGTON—Covington has announced that its partners have unanimously elected Doug Gibson as chair of the firm’s Management Committee and that he will begin a four-year term on January 1, 2020. In both the United States and European Union, many of the products used in these strategies are regulated as ... Daniel Suleiman and Amanda Kramer spoke with Law360 about the safe harbor deadline established by the Small Business Administration for companies that may have improperly taken out loans through the Paycheck Protection Program. Data, Innovation, and ... WASHINGTON—Law360 has named Covington as one of its 2018 “Firms of the Year” for earning seven Practice Group of the Year awards. The FDIC for some time has been exploring the extent to which the current regulatory ... WASHINGTON—Covington advised Merck & Co., Inc. on its acquisition of Antelliq Group for approximately €2.1 billion ($2.4 billion) plus the assumption of €1.15 billion of debt. The CRA, enacted in 1977, incentivizes banks to meet the credit needs of their entire communities, including low- and moderate-income (“LMI”) neighborhoods. Mr. Nonaka says it will be a while before any fintech firms operate as national banks, and they may ultimately decide the special purpose charter does not suit their ... July 30, 2018, WestLaw Journal, Government Contract. Ms. Jones ... February 17, 2021, Center for Strategic & International Studies. Mr. Rubman says lawyers might have to take more time to go over certain technical issues with less experienced judges. Even though Schrems II invalidated the Privacy Shield with immediate effect as a matter of EU law, U.S. regulators swiftly indicated that they will continue to administer the Privacy Shield and that self-certified ... Karen Solomon is quoted in the American Banker regarding the Office of the Comptroller of the Currency’s new charter license for payments companies. The CFTC would have 10 days to review that decision or ... Susan Cassidy is quoted in Law360 regarding the DoD’s implementation of cybersecurity requirements for defense contractors. I counted up, it was 17 people at the meeting and I was the only woman. [1] Group standards can ... Robert Kelner is quoted in Law360 regarding the increased scrutiny over Paycheck Protection Program loans following the overhaul of Democratic leadership. According to Ms. Clark, to complicate matters even more, some states have implemented their own definitions of "essential," creating potential conflicts with federal guidance and confusion over ... David Martin is quoted in Agenda regarding the increased importance for companies to take up environmental, social, and governance (ESG) issues. At the conference, panelist lawyers said the Consumer Financial Protection Bureau should not wait to provide a definition of what counts as an "abusive" act or practice under the Dodd-Frank Act. Earlier this year, President Trump signed into law the Bipartisan Budget Act of 2018 (BBA), which incorporates provisions from the Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act of 2017 and improves access to telehealth services in Medicare Advantage. Ms. Clark says, “It’s inevitable to find Huawei prevalent in systems across China, Europe, and Africa. Once finalized and effective, the regulations will govern the process and procedures that the Secretary of Commerce ... Last week, the United States Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) published Draft Guidance for Industry No. The SEC and its staff continue to respond to the COVID-19 pandemic by providing public companies and other filers with relief from certain reporting requirements, as well as rule amendments. The amendments are intended to reduce the complexity and costs associated with ... Witney Schneidman is quoted in Law.com International regarding the postponement of the African Continental Free Trade Area (AfCFTA) due to a concentration on limiting the spread of COVID-19. Daniel Cho was apart of a winning team of Covington lawyers who represented Omeros Corp. in a generic cataract drug case. Mr. Kelner says, “This is not an issue just for lobbying firms and public relations firms because FARA sweeps very broadly and applies to ... WASHINGTON—The National Asian Pacific American Bar Association (NAPABA) has recognized Nooree Lee with its Best Under 40 Award. Antitrust Agencies Announce Proposed Changes to HSR Rules, FCC Formalizes Foreign Investment Review Process, Covington Promotes 14 to Partner Across Six Offices Globally, Fed CRA plan seen as bridging divide with OCC, Web Of 'Wellness' Doctors Promote Injections Of Unproven Coronavirus Treatment, Two Covington Lawyers Named to National Black Lawyers 40 Under 40 List, Attorneys say Defense Dept. Among other things, the Order is an initial step toward accomplishing the Biden Administration’s goal of building more resilient American supply chains that avoid shortages of critical products, facilitate investments to ... WASHINGTON—Andrew Smith, most recently the Director of the Bureau of Consumer Protection at the Federal Trade Commission, has rejoined Covington as a partner in its Advertising and Consumer Protection, Data Privacy and Cybersecurity, and Financial Services practices. The ongoing partial government shutdown has halted most operations of the agencies regulating product safety, including the Consumer Product Safety Commission (“CPSC”), the National Highway Traffic Safety Administration (“NHTSA”), and the Environmental Protection Agency (“EPA”). The past year was a particularly significant one for the development of Chinese privacy law. “Our new partners are exceptionally talented lawyers from a wide range of the firm’s offices and most important practices, and they are extremely well-positioned to carry the firm forward,” ... For over 30 years, the Committee on Foreign Investment in the United States (“CFIUS” or the “Committee”) focused on a narrow subset of M&A transactions and investments. Ms. Katz says clients have asked the firm to reply to the official listed as the contact on the records request and “ask for a teleconference to discuss the request and make sure that the things you’re providing are effective and responding and that you ... Karen Solomon is quoted in Bloomberg Law regarding FDIC Chair Jelena McWilliams's final potential acts as part of the Trump administration as it relates to "valid when made" and "true lender" rules. How the Upcoming Election Could Change Privacy Law in the U.S. Covington Named Among Top Five Investigations Practices Globally, The Final U.S. Net Stable Funding Ratio: Six Things To Know, U.S. regulators approve new-look liquidity rule despite opposition, Covington Receives Human Rights First’s 2020 Marvin E. Frankel Award for Pro Bono Service, The Banking Agencies’ Proposed Rule on Supervisory Guidance: Six Things To Know, Firms vie for dominance in new sustainability law practices, Lobbying revenue stays strong despite pandemic election, Cell-Cultured Meat Startups, NAMI, Urge USDA to Gather More Data Before Issuing a Proposed Rule on Labeling, China Adds New Export Restrictions in Latest Trade Dispute Move, Less Interagency Spectrum Policy Dysfunction Likely No Matter Next President, Think Tanks — Administration Demands Foreign Funding Diclosure, CFTC records another year of aggressive spoofing enforcement, CFPB Enforcement Sees Highest New Case Volume In 5 Years, Ichiro (“Ike”) Morinaga Promoted to Senior Of Counsel, Covington Represents TriState Capital in $105M Capital Raise, SEC Targets Small Accounting Adjustments in First Enforcement Actions Under Earnings-Per-Share Initiative, Time For Independent FDA? How Four Big Federal Contracts Rulings Will Echo Into 2021, Antitrust Division Brings First Criminal Wage-Fixing Charge, BSA/AML Reform in the 2021 NDAA: Seven Things To Know, What You Can Do to Protect Your Dependent Care FSA Cash, Global Data Review Names Covington to The GDR 100 Elite, FDA Advertising and Promotion Enforcement Activities: Update, Getting U.S. Policy toward Mexico and Canada Right, Center for Strategic and International Studies, Variety Recognizes Stuart Irvin and Adrian Perry in 2020 Dealmakers Impact Report, Glass Lewis Issues 2021 Updates to Policy Guidelines, Cheesecake Factory Penalty Signals Shift In SEC Virus Focus, Vitol Settlement Previews CFTC’s Foreign Corruption Crackdown, SCOTUS spotlight: Beth Brinkmann on cracking the glass ceiling, CFTC OKs Electronic Trading Rules, Revises Bankruptcy Code, Covington Assists Veritas Capital with Federal IT and Mission Support Services Acquisition, Historically fruitless Congress highlights Biden challenge if Senate stays red, Nasdaq Proposes Board Diversity Listing Requirements, An IPO is when a company starts trading on a public exchange, offering investors a chance to get in on a hot new stock, California Employers Must Comply with New Cal/OSHA COVID-19 Workplace Safety Standards, Singapore just became the first nation to approve cell-cultured meat for human consumption, The OCC’s Part 7 Final Rule: Five Things to Know, A Look at the SEC Enforcement in 2020 and the End of Chairman Clayton’s Tenure, Lessons On Gov't Contractor Employees' Apparent Authority, COVID-19 and Workforce Reorganizations Part Three: External Events—Managing the Unexpected, Covington Again Named Law360 Firm of the Year, California AG Settlement Suggests Privacy and Security Practices of Digital Health Apps May Provide Fertile Ground for Enforcement Activity, PR Urged to Monitor Foreign Agents Registration Act, Opening the Doors: Return-to-Workplace Considerations During COVID-19, Part Eight: The COVID-19 Vaccine and the Workplace, FTC Provides Guidance on Use of AI and Algorithms, COVID-19 and Workforce Reorganizations Part Two: Global Reductions in Force, Can We Talk? The company said that it planned to keep around 750 employees in its former headquarters. It is not fringe anymore, which doesn’t mean mainstream companies are ready to jump in. Poison prevention has been one of several top priorities of the U.S. Consumer Product Safety Commission (“CPSC”) during the COVID-19 pandemic. NEW YORK—Latinvex has named Covington among the top ten international law firms doing work in Latin America and first among firms in trade & sanctions. On June 25, 2020, five federal financial regulators jointly issued a final rule that modifies existing regulations implementing the Volcker Rule’s general prohibition on banking entities investing in, sponsoring, or having certain relationships with hedge funds or private equity funds (collectively, “covered funds”). He served as Chief Counsel of the U.S. Food and Drug Administration from 2007 to 2009. Mr. Hanson notes that diagnostic testing “presents an array of regulatory considerations” in the U.S., such as checking whether a test has been approved by regulators. Journal of Robotics, Artificial Intelligence & Law, The Review of Securities & Commodities Regulation, Global Legal Insights - Pricing & Reimbursement, Intellectual Property & Technology Law Journal, The Journal of Robotics, Artificial Intelligence & Law, Pratt's Privacy & Cybersecurity Law Report, American Bar Association's 33rd Annual National Institute on White Collar Crime, Privacy Laws & Business International Report, The Internet of Things - Legal Issues, Policy, and Practical Strategies, Covington Comment Letter to The Honorable David J. Kautter and The Honorable William M. Paul, PLI Course Handbook, Internal Investigations, Understanding H.R. Courts are now more likely to find ... On May 19, OSHA issued updated guidance reinstating employers’ obligations to record work-related COVID-19 cases. In the wake of destructive cyber incidents over the past few years, the insurance industry and its regulators have focused more attention on so-called “silent cyber” exposures in traditional property/casualty insurance policy forms and started taking steps to reduce or specifically address those exposures. "Ultimately, the outcome of this case could affect almost everyone in the country.” She adds that the case is “by far the most important case to watch in 2020.”. Mr. Sylvester says, “USDA has not yet invited public comment on the labelling of cell-cultured meat & poultry but is expected to do so in due course. Its products and services are designed to benefit people by supporting efforts to overcome the ... Federal and state policymakers continued to focus on artificial intelligence (“AI”) and the Internet of Things (“IoT”) in the second quarter of 2019, including by introducing both substantive measures that would regulate the use of the technology and by supporting funding bills aimed at increasing investment. Shara Aranoff, International Trade. This ... Mike Nonaka is quoted in Law360 regarding the New York Department of Financial Services and the Conference of State Bank Supervisors’ fintech charter, which is being challenged for its validity in the Southern District of New York. This is the fifth year in which the firm has been recognized on the list. Yesterday, in response to industry requests for labeling flexibility in order to shift such ... Susan Cassidy spoke with Federal Computer Week about the concerns of defense contractors under the coronavirus relief package. Ms. Solomon says, “CSBS, for example, has released a series of recommendations aimed at streamlining and simplifying the multiple state requirements that apply when nonbank firms conduct business across state ... June 14, 2019, Government Contracting Law Report, June 11, 2019, Global Investigations Review. Now in its 20th year, GCR100 undertakes extensive analysis of antitrust and competition law groups in ... WASHINGTON—The Human Rights Campaign Foundation (HRC) has awarded Covington a perfect score of 100 percent for the twelfth consecutive year on its Corporate Equality Index (CEI), a national benchmarking survey and report on corporate policies and practices related to LGBTQ workplace equality. Trump holds fire in trade fights with Europe and China — but for how long? Government Contracts WASHINGTON—The American Lawyer has named Covington to its 2018 “A-List,” an annual ranking of the top 20 firms based on revenue per lawyer, pro bono commitment, diversity, associate satisfaction, and the percentage of female equity partners. Mr. Sylvester says, “I expect cell-based meat to take center stage in the evolving food regulatory conversations occurring in the U.S. and around the world. For them, it's not a legal ... Peter Hutt is quoted in a Law360 article providing takeaways from a recent challenge to the Justice Department’s investigative powers. Unlike most countries of its size, the U.S. does not yet have a broadly applicable data ... WASHINGTON—Global Investigations Review has ranked Covington among its top five in its annual GIR 30, a list of the leading global firms best suited to handle sophisticated cross-border government-led and internal investigations. The rule provides clarity for hemp growers and related businesses and is a critical next step after the passage of the 2018 Farm Bill last December. “This was about getting to her at home, about making her feel afraid,” Ms. Saulino told the jury. Andrew Jack is quoted in a Bloomberg article regarding the push by employees and investors of Google's Alphabet Inc. to tie executive pay to progress on workplace diversity, According to Jack, investors care about environmental, social, and governance (ESG) issues. Federal Legislation On March 23, Jones and Paul Schmidt secured the first victory, and on May 7, she achieved another defense win before a Connecticut ... Alexander Berengaut and Jeffrey Davidson are quoted in a Law360 article regarding upcoming oral arguments related to the DACA challenge in which Covington represents the University of California. Hoe says that increase could draw a reaction from other countries if their companies find it more difficult to participate in U.S. deals. According to Ms. Anderson, authorities in the U.S. have only general legal tools to seek access to encrypted data. 748, the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”). Covington has represented the University of ... Miriam Guggenheim spoke with Politico about the proliferation of CBD retailers and manufacturers and the wave of recent class-action lawsuits. Ms. Dohm ... June, 2020, Privacy & Cybersecurity Law Report. The transaction is expected to close in the first half of 2021. He notes that the agency has been working hard to avoid the need for pre-approval inspections by, for example, requesting records and talking ... On August 19, the Department of Health and Human Services (HHS) announced a new policy concerning laboratory developed tests (LDTs). As large companies across the globe continue to navigate the ongoing COVID-19 pandemic, many are considering workforce reorganizations as a way to reduce costs in light of geopolitical and economic uncertainties, flagging demand, and a rapidly changing outlook for recovery. According to the publication, “Nicole Duclos is a skilled practitioner ... Randy Benjenk spoke with Law360 about the Office of the Comptroller of the Currency’s overhaul of bank regulations of lending to low-income and underserved communities. US FDA Remote Records Review Missteps Worry Industry, FDIC Chair McWilliams Plans to Stay as Board Faces Biden Shift, A Primer for Navigating the Presidential Appointee Vetting and Confirmation Process, Michael Nonaka Named to Global Banking Regulation Review’s 45 Under 45, Insurer Can't Cap Coverage In $85M Tornado Suit, What a Biden Win Means for Comp Committees, Key Issues for FDA in a Biden Administration, FDA Holds Public Meeting on Food Traceability Proposed Rule, Third Circuit Addresses the Scope of the FCA’s First-to-File Bar, 5 Predictions For Banking Regulation In A Biden Presidency, Biden's Win Means Big Business For BigLaw, FERC Opens Electricity Markets to Distributed Resource Aggregators, Avatar IP Considerations For Music-Gaming Integration, Nominees to Dominate Banking Committee Agenda, These are the big law firms Trump and Biden could tap if the election ends up in court, Guidance Regarding Contributions to Recount and Election Dispute Funds, Lobbyists prepare to navigate a divided Senate, Senate — And Pandemic Relief — Still Hanging In The Balance, Short Primer on the Administrative Law of Bank Regulation, Three Covington Partners Named Law360 MVPs, The SEC’s Final Rule on Guide 3 Disclosures: Eight Things To Know, Lawyers: Congress, not FDA, will legalize CBD in supplements, Covington Named to The National Law Journal's 2020 "Appellate Hot List", Covington Represents GovernmentCIO in Sale to Private Equity Firm, Outlook for Congressional Investigations After the 2020 Elections, What to Do When Off-Duty Employees Aren’t Social Distancing, The November Election and Implications at the FDA: Key Issues to Watch, Reforming The FEC: Bipartisan Compromise Is Essential. Will coronavirus hasten arrival of fully remote bank exams? Spring 2019, PLI Current: The Journal of PLI Press. Witney Schneidman appeared on CGTN’s The Heat to discuss “China and the West in Africa.”. Whilst some types of non-essential businesses have subsequently been ... Karen Solomon spoke with Law360 about the Office of the Comptroller of the Currency’s push to speed up the digital transformation in banking. Is Fed taking too long on middle-market loan relief? Mr. Poloncarz says, “Covington [is] renown for regulatory expertise in D.C. on federal matters, and that was very much a draw for me. On August 4, 2020, OEHHA, the California agency in charge of Prop 65 announced a proposed regulation that, when final, would exempt from Prop 65 products containing listed chemicals introduced through cooking or heat-processing. Ms. Termine says, “The commission is trying to thread the needle of registration that is not over-reaching beyond our borders, yet sufficiently protects the interests of the U.S. and U.S. markets. She later supervised the amicus briefs ... Eric Mogilnicki is quoted in Law360 regarding the CFPB’s new policy of restraint in bringing enforcement actions against financial services providers for abusive acts and practices. All Rights Reserved. This list profiles 50 lawyers who have "moved the needle" and are making great strides as finance and technology grow more entwined. Waking Up To a New Reality: Where is Mexico Heading? "While there is much progress still to be made, these results are a reflection of Covington's sustained efforts to recruit, mentor, develop, promote, and ... Today (June 20, 2018), FDA published in the Federal Register the availability of the first four chapters of a nine-chapter draft guidance (“IA draft guidance”) intended to address the requirements in its final rule, Mitigation Strategies to Protect Food Against Intentional Adulteration (“IA rule”). It does happen, and this was a big meeting. This e-alert is part of a series of e-alerts summarizing publicly available U.S. Food and Drug Administration (FDA) enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics. Shara Aranoff is quoted in Law360 regarding the firm’s victory before the U.S. International Trade Commission’s regarding tariffs imposed Canadian imports on newsprints.
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