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The News in Depth

Congressional Committee Has More Questions for J&J’s Weldon

J&J’s CEO William Weldon has been invited to appear before the House Committee on Oversight and Government Reform to explain the contents of e-mail messages uncovered in the committee’s investigation into the company’s recall of children’s medicines earlier this year....

MHRA Inspectors Will Look For “Risk Registers,” SOPs and Periodic Review in Quality Risk Management Systems

British inspectors when inspecting drug manufacturers will be looking for a “risk register” and a defined document management control system including periodic reviews of risk management assessments, according to a “frequently asked questions” (FAQ) document recently-published by the UK's Medicines and Healthcare products Regulatory Agency (MHRA)....

FDA Gathering Biosimilar Stakeholders for Input on Implementing the New Legislation

FDA will be holding a two-day public hearing to obtain input on specific issues and challenges associated with the implementation of the new biosimilars legislation. The meeting is set for November 2-3 at FDA’s White Oak campus in Silver Spring, MD....

US House Proposing to Equip and Fund FDA for Increased Global Oversight

Key players in the US House of Representatives have put on the table a draft of comprehensive legislation aimed at strengthening FDA’s recall and overseas inspection authorities and requiring new supply chain accountability for drug companies. The bill is intended to help FDA respond to the increasing challenges it faces in regulating a global pharmaceutical marketplace....

Excipient Master File System Advocated for EU

An excipient master file (EMF) system in the EU would facilitate the review process, spur excipient R&D and harmonize with other regulatory systems, advocates are saying....

Ongoing FDA Concerns with Procedure Compliance, Media Fill Practices and Environmental Excursions at BMS’ Manati, PR Plant Draw Warning Letter

Findings by FDA during a mid-March inspection at Bristol-Myers Squibb’s (BMS) injectable operations in Manati, Puerto Rico of problems with procedure and media fill compliance – previously noted in 2005 and 2009 inspections – contributed to a late-August warning letter to the firm....

KV Resumes Drug Shipments of Its First Product After Successful FDA Inspection

KV Pharmaceuticals announced on September 10 that it will restart shipment of its potassium chloride capsule product Micro-K after a successful inspection in August of its St. Louis facility and a letter from FDA this month giving the firm permission to resume manufacturing and distribution of the product....

FDA and EMA Extend Confidentiality Agreement “Indefinitely”

FDA and the European Medicines Agency (EMA) are extending their confidentiality agreement covering information-sharing on human and veterinary medicine products “indefinitely without the need for further renewal” due to positive experiences by both agencies during the seven years the agreement has been in place....

McNeil’s 2000–2010 Inspection Record Shows a Mixed Bag of Compliance for its PA and PR Sites

Since mid-July, FDA has made public 483s and establishment inspection (EIR) reports from 17 inspections of McNeil facilities, showing a mixed bag of compliance over the last decade....

Willing Parties, Quality Agreements and Information From Suppliers All Needed For Supply Chain Risk Management, CDER’s Friedman Stresses

Willing parties, quality agreements and information from suppliers are all needed along with auditing programs in managing pharmaceutical supply chain risks, CDER Office of Compliance Division of Manufacturing and Product Quality (DMPQ) Director Richard Friedman stressed in addressing industry/regulator initiatives to strengthen supply chain integrity....
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