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The News in Depth

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....

Cooperative Supply Chain Integrity Efforts Important to Support Advancing Track-and-Trace/Authentication Technologies and QC Analytical Methods

Broad-based cooperation vertically across the supply chain and horizontally across organizations and regions is important to help support the advancements in track-and-trace/product authentication technologies and QC analytical methods, CDER compliance official Richard Friedman emphasizes....

Update From FDA on its Secure Supply Chain Pilot Coming Soon; Regulation, Legislation and Guidance Efforts Advance in US and EU

A status update and further announcements from FDA on its “Secure Supply Chain” (SSC) pilot program, intended to help promote the safety of active ingredients and drug products imported into the US, is expected soon....

MHRA Has Been Rejecting One-Third of Type IA Variation Notifications Due to Information Shortcomings

Almost one-third of Type IA variation notifications are being rejected by Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) due to not meeting the filing criteria or including the right administrative information, according to an assessment by MHRA covering the six months since the new EU variations regulations became effective....

Gemfibrozil Manufacturing Problems at Sun’s NJ Facility Among Issues Prompting FDA Warning Letter

Gemfibrozil manufacturing problems resulting in imploding sample bottles and unknown impurities and how they were responded to were central concerns highlighted in an FDA warning letter to Sun Pharmaceuticals in late August regarding inspection findings at the Indian generic drug company’s Cranbury, New Jersey facility....

Warning Letters to Two Overseas Sterile Ophthalmic Manufacturers Cite Similar Microbial Control Practices

FDA has issued warning letters to two foreign-based aseptic ophthalmic firms citing a strikingly similar litany of problems with procedures and practices designed to prevent microbial contamination....

Separate Review Track Proposed for Design Space to Avoid Marketing Application Approval Delays

A separate review track for design spaces could allow more room for industry/regulator dialogue on the issues involved without delaying the clearance process for the marketing application, Health Canada Center for the Evaluation of Radiopharma-ceuticals and Biotherapeutics Director Anthony Ridgway suggested at a CMC Strategy Forum on implementing quality by design (QbD) cosponsored by the biotech science society CASSS and FDA in mid-July....

FDA Concern with Particle Contamination and Related Investigations Resurfaces in Warning Letter to Sterile Drug Contract Manufacturer

A mid-August warning letter addressing March inspection findings at contract drug manufacturer Hyaluron highlights FDA’s ongoing concerns with particulate contamination problems and their investigation in aseptic manufacturing. The warning letter was issued to the CEO of New York-based Albany Molecular Research, Inc. (AMRI) which purchased ten-year-old Hyaluron in June after the inspection....
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