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Focus on Regulation

Tag Archives: Inspection

FDA, EU Regulators Agree to Share Unredacted Inspection Reports and Other Confidential Information

The U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the European Commission – DG Sante (DG Sante), signed a new confidentiality commitment which expands the scope of the current confidentiality arrangements that apply to the cooperative law enforcement activities conducted by the regulators.  The new confidentiality commitment allows the regulators to share

EMA Publishes New Union Procedure on the Management of Pharmacovigilance Inspection Findings

On 20 June 2014, the European Medicines Agency (hereafter “EMA”) published a new European Union procedure on the management of pharmacovigilance inspection findings which may impact the robustness of the benefit-risk profile of the concerned medicinal products (“new EU Procedure”). The new EU Procedure came into effect on 1 June 2014.

One of the aims of the new European Union (“EU”) pharmacovigilance legislation, which entered into force on 28 October 2013, is to reinforce the harmonization of pharmacovigilance inspections in the EU. Furthermore, the new legislation aims to enhance cooperation among the relevant individuals and entities involved in pharmacovigilance inspections. These include the inspectors, the pharmacovigilance assessors in the EU Member States, the Pharmacovigilance Inspectors Working Group and the Pharmacovigilance Risk Assessment Committee (“PRAC”).

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.

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