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Focus on Regulation

Tag Archives: Compliance

FDA to Rely on Drug Inspections Performed by Certain European Regulatory Authorities Beginning November 1, 2017

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. 

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

U.S. Department of Education Delays Implementation of Certain State Authorization Requirements until July 1, 2015

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

Hogan Lovells to Host FDLI cGMP Conference: Top FDA/CDER Compliance Officials Will Speak on a Range of cGMP Issues

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.

Amendments to German Antitrust Law – Impact on M&A Transactions and Compliance Programmes

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

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

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

U.S. Department of Transportation Denies Request for Enforcement Moratorium Extension on New Baggage Rules

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

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