On July 31, 2019, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) published a joint report on their efforts to support the development of and expedite access to breakthrough therapies that address unmet medical needs. In addition to outlining the tools currently available to manufacturers seeking expedited approval of breakthrough
On November 9, FDA Commissioner Scott Gottlieb, M.D., announced that the agency launched new inspection protocols for aseptic processing of sterile drugs to be used by FDA investigators during surveillance and pre-approval inspections. The protocols were developed through the agency’s New Inspection Protocol Project (the “NIPP”), initially launched in 2014. The NIPP is intended to
On October 18, the Federal Trade Commission (FTC) announced it settled charges against California-based Regenerative Medical Group, Telehealth Medical Group, and the founder of both companies, Dr. Bryn Jarald Henderson, based on deceptive stem cell therapy claims. In its complaint, the FTC alleged Henderson and the companies made unsupported claims, including that “amniotic stem cell
On Tuesday, FDA announced the entry of a consent decree of permanent injunction against Keystone Laboratories, Inc. of Memphis, Tennessee for manufacturing OTC hair care and skin care products in violation of Current Good Manufacturing Practice (cGMP) requirements and for failing to include required labeling. Under the 24-page decree, a federal court enjoined the defendants,
Yesterday, FDA published a January 3, 2018 Warning Letter issued to American CryoStem for marketing Atcell—an adipose tissue derived stem cell product—without FDA approval and for several drug current Good Manufacturing Practice (GMP) violations observed during FDA’s July 2017 inspection of American CryoStem’s New Jersey facility. In a related press release, the agency cited the
Earlier today, FDA announced that it has determined that the regulatory authorities of Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the United Kingdom are “capable of conducting inspections of [pharmaceutical] manufacturing facilities that meet FDA requirements,” and that the Agency will begin relying “on the inspectional data obtained by these eight regulatory agencies” immediately.
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
On June 24, the U.S. Department of Education further delayed the implementation date for certain state authorization regulations for colleges and universities that have been unable to meet the requirements of those regulations—so long as (1) the state in which the college or university is located is working to establish an acceptable authorization process that
The Food and Drug Law Institute (FDLI) will hold its “Understanding cGMPs—What Attorneys Need to Know” conference at the Washington, DC office of Hogan Lovells on July 15, 2014. During the conference, which is specifically tailored for lawyers but appropriate for all drugs and biologics stakeholders, attendees will hear from top FDA/CDER Compliance officials, in-house counsel, Hogan Lovells’ lawyers, and others, on how FDA evaluates company compliance with current good manufacturing practice (cGMP) and responds to noncompliance. The conference will highlight recent cGMP developments and provide updates on FDA authority. It will also expand beyond the United States to consider global issues such as import/exports and international inspections.
On 30 June 2013, the Eighth Amendment to the Act Against Restraints of Competition (“ARC”) came into force in Germany. This reform introduces important changes to German merger control law and to the regulation of abuse of dominance. Business should take careful note of these changes for their M&A transactions and for their antitrust compliance
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
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
The United States Department of Transportation (“DOT”) has denied the request by several airline trade associations to extend its moratorium on enforcing certain aspects of the new baggage rules, 14 CFR Sections 399.85(c) and 399.87. DOTDenial of Extension. Airlines for America, the International Air Transport Association, the Regional Airline Association, and the Air Carrier Association
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