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The News in Depth

FDA/EMA Joint Inspection Program for Finished Products Seeking Applicants

The EMA is continuing to seek drug manufacturers willing to participate in its joint inspection program with FDA for finished products. In an August 11 announcement, EMA explained that companies that have submitted two equivalent applications for the same product to both EMA and FDA can request to participate in the pilot....

New Senate Bill Proposes Supply Chain Requirements for Drug Firms, Mandatory Recall Authority for FDA

A bill introduced in the Senate in early August would amend the Food, Drug and Cosmetic (FD&C) Act to provide FDA with new monetary penalty and recall tools and require drug firms to audit and document the steps in their product ingredient supply chains....

FDA Releases Q&A on Recalls, Holding and Distribution of Human Drugs

FDA provided on its website in early August a Q&A giving additional guidance on human drug recalls – their purpose, FDA’s authority to mandate them, over-the-counter (OTC) drug versus prescription drug recalls, and related investigations....

CDER Will Focus on Part 11 Compliance in Upcoming Inspections

FDA’s Center for Drug Evaluation and Research (CDER) will be conducting a series of inspections of drug manufacturers that will evaluate the industry’s understanding of and compliance with the Part 11 regulations. The inspection findings will be used to assess whether or not its related regulations and guidance need to be adjusted....

MHRA Pursuing New Monetary and Statutory Sanctions for Non-compliance

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is actively exploring the addition to its enforcement toolbox of a range of monetary and statutory sanctions for use against non-compliant drug manufacturers, similar to those available to FDA....

EU Restructuring PAT Team to Help Address Communication Challenges of the New Quality Paradigm

The EMA is restructuring its PAT Team to advance the team’s role in facilitating the communication within the agency and with industry needed to further the ICH Q8-10/QbD objectives....

ICH Q4B Annex 13 on Powder Density and Annex 14 on Bacterial Endotoxin Testing Out for Comment

FDA has made available for comment the Step 2 drafts of ICH Q4B Annex 13 covering the bulk density and tapped density of powders and Annex 14 on bacterial endotoxin testing. The drafts were cleared for release by the ICH Steering Committee meeting in June....

WHO Proposes New Guideline for Microbiology Labs and Adjustments to Site Master File, Water and HVAC Guides

WHO is expanding its guidance library to focus specifically on GMP expectations for microbiology labs and is adjusting its existing guidelines on drafting site master files, on water used in pharmaceutical manufacturing and on heating, ventilation, and air-conditioning (HVAC) systems....

Complaint and Deviation Handling, Contamination Control Continue to Draw FDA Attention at Vaccine Plants

Complaint and deviation handling/reporting and contamination control – concerns that have been in the forefront of FDA attention during vaccine manufacturing inspections – were again focal points at a March/April inspection of Sanofi Pasteur’s vaccine plant in Marcy l’Etoile, France that resulted in an “untitled letter” from the agency on July 22....

Understanding Biosimilar/Biobetter Approval Pathways and Differences Key to Success, Merck Exec Says

Success for both biotech innovator companies and biosimilar manufacturers under the new health care legislation will require working with FDA to optimize the regulatory approval pathways and understanding the key differences between biosimilars and biobetters, a Merck executive maintained in a recent interview....
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