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Focus on Regulation

Tag Archives: Enforcement

FDA Clarifies and Expands Eligibility for RMAT Designation for Gene Therapies

On November 16, in the context of announcing a comprehensive regenerative medicine policy framework (discussed here), FDA released a draft guidance document that describes the expedited programs available for the development and review of certain regenerative medicine therapies.  Importantly, the draft guidance clarifies certain aspects of the Regenerative Medicine Advanced Therapy (RMAT) designation established by

FDA Issues New Guidance Documents on Regenerative Medicine but Delays Enforcement

Yesterday, the U.S. Food and Drug Administration (FDA) announced a comprehensive framework for development and oversight of regenerative medicine products, including innovative cell-based therapies.  This initiative builds on the agency’s existing framework to set forth more clearly which products are subject to regulatory enforcement. In September, as we previously discussed here and here, FDA’s Commissioner,

UK Food Standards Agency reviewing Feed Law Code and Guidance

The UK Food Standards Agency (FSA) is consulting on its proposals to amend the Feed Law Code of Practice and Practice Guidance. The Code and Guidance have to be taken into account by local authorities when enforcing feed law requirements in England (there are separate documents for Wales, Scotland and Northern Ireland).

Continuing Coverage of FDA’s Crackdown on Stem Cell Clinics: Florida Clinic Cited for Unapproved Marketing and Inadequate Sterility Assurance

On the same day that FDA’s Commissioner, Dr. Scott Gottlieb, announced new policy initiatives regarding stem cell therapies and regenerative medicine, FDA announced stepped up enforcement in this area and posted a warning letter issued to U.S. Stem Cell Clinic located in Sunrise, FL.  FDA issued the warning letter following an inspection beginning in April

FDA Seizes Stem Cell Therapy—A First of Many?

On August 25, 2017, U.S. Marshals Service, at the request of FDA, seized five vials of ACAM20000—a smallpox vaccine containing live vaccinia virus (cow pox), which is reserved for people at high risk of contracting the disease—that were discovered during an FDA inspection at StemImmune Inc., a San Diego, California company that purports to specialize

U.S. FDA and EU Regulators Announce Enhanced Mutual Recognition for Pharmaceutical Manufacturing Inspections; Allows FDA to Continue Shifting Inspections and Enforcement Focus to Asia

In an effort to avoid the duplication of drug inspections, lower inspection costs, and enable regulators to devote more resources to other parts of the world where there may be greater risk, the U.S. Food and Drug Administration (FDA) and the European Union (EU) today announced that they have enhanced their agreement on mutual recognition

FCC Fines More Companies for Wi-Fi Blocking

On November 2, 2015, the U.S. Federal Communications Commission issued two proposed fines related to Wi-Fi hotspot blocking.   In the first notice the FCC proposed a penalty of $718,000 against M.C. Dean, one of the largest U.S. electrical contracting companies, for allegedly interfering with and disabling the operation of consumers’ Wi-Fi devices at the Baltimore

FCC Issues Notice of Violation to Nike for Corporate Wireless System

In the latest example of increased FCC enforcement activity, the agency’s Enforcement Bureau has issued a Notice of Violation to Nike Inc., for interference caused by a defective UHF amplifier card in Nike’s corporate Distributed Antenna System (“DAS”) network.  The Notice is an important reminder for all companies that operate wireless equipment to keep a

Hot Topics at FDLI Enforcement, Litigation and Compliance Conference

Topics discussed at the recent Food & Drug Law Institute’s (FDLI) Enforcement, Litigation and Compliance Conference included FDA Center leaders’ enforcement priorities, interagency enforcement actions, the implications of increasing globalization, and the diversion of controlled substances.  Among the highlights: Joseph Rannazzisi, Deputy Assistant Administrator in DEA’s Office of Diversion Control, said due diligence is the

FDA Suspends Sunland’s Registration; First Use of New Suspension Authority

On November 26, the Food and Drug Administration (FDA) suspended the food facility registration of Sunland, Inc., a producer of nuts, and nut and seed spreads. Notably, this is the first time FDA has used its registration suspension authority, which was established by Section 102(b) of the FDA Food Safety Modernization Act (FSMA). Significantly, this

Updates from FDLI’s Advertising & Promotion Conference and the Pharmaceutical & Regulatory Compliance Congress

Recently, industry leaders, members of the FDA bar, and government officials convened at the Food & Drug Law Institute’s (FDLI’s) Advertising & Promotion Conference and the Pharmaceutical & Regulatory Compliance Congress. Topics included policy updates and enforcement priorities from FDA’s centers, Office of Inspector General (OIG) and Department of Justice (DOJ) current and future enforcement

California AG Sends Enforcement Letter to Developers of Popular Mobile Apps

On Tuesday, October 30, the Office of California Attorney General Kamala Harris issued a press release confirming that it had begun “formally notifying” mobile device application (“app”) operators that they are out of compliance with the notice provisions of the California Online Privacy Protection Act of 2003 (“CalOPPA”).  Those companies — many of which are major marketers — now

FDA’s Changing Culture: What Food Companies Need to Know

The Food and Drug Administration (FDA) is undergoing a major culture change, and nowhere is that impact being felt more than in the food industry.  While visibly preparing new regulations to implement the Food Safety Modernization Act (FSMA), the agency has quietly become much more inspection-oriented and enforcement-minded, even under its historic authorities.  Here is