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Incomplete NDA/ANDA Cover Letters Are Causing FDA to Delay Preapproval Inspections

Incomplete or inaccurate facility information on NDA/ANDA form 356h cover letters are causing decisions on conducting preapproval inspections (PAIs) to be delayed or tabled, FDA field managers are reporting.

FDA Renews Request to Congress for Additional Supply Chain Authorities

At a US Senate hearing on September 14, FDA renewed its request for new tools to more effectively and efficiently oversee the global supply chain and better protect the public from substandard, adulterated and counterfeit drug products....

FDA’s Foreign Office Experience Supports Their Benefit to Global Supply Chain Regulation

FDA’s growing experience with the field offices it has established in India, China and eight other countries is substantiating their benefit in boosting the agency’s efficiency and effectiveness in regulating a global supply chain....

Part 11 “Add-on” Coverage to FDA Surveillance Inspections Shedding Light on Industry Gaps

FDA is getting a better handle on where industry is having problems applying Part 11 as the results from its “add-on” coverage of computer systems during routine surveillance inspections begin to emerge....

Recent PET Drug Inspection Findings Shed Light on Upcoming FDA Focal Points

Recent inspection findings at positron emission tomography (PET) drug manufacturing facilities regarding sterility assurance, testing, training and quality oversight provide insight into what FDA investigators will be looking for when inspecting these manufacturers – most for the first time....

FDA Unapproved Drugs Initiative Orders Hundreds of Cough/Cold Products off the Market

FDA is taking another significant step in its unapproved drug enforcement initiative by ordering that hundreds of oral prescription (Rx) drugs used to treat coughs and colds be taken off the market....

Deltex Injunction Follows History of Lab GMP and Unapproved Drug Compliance Problems

An injunction against Texas-based prescription and over-the-counter (OTC) drug contract manufacturer Deltex is forcing the firm to shut down operations and recall all products manufactured since it received an FDA warning letter in 2008....

FDA Preapproval Inspections Enhanced by New Guidance, Reviewer Participation

Increased reviewer engagement with investigators is impacting the preapproval inspection (PAI) process and helping FDA address the growing complexity of products and processes it faces in reviewing new drug applications (NDAs) and their supplements (sNDAs)....

Japan’s Foreign Inspections Reveal Communication Chain Gaps

Foreign inspections by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) are revealing gaps in the communication chain between marketing authorization holders in Japan, their overseas suppliers and the Japanese caretakers of the supplier’s master files, PMDA’s Liaison Officer with EMA Yoshikazu Hayashi reported at the annual meeting of the Active Pharmaceutical Ingredient Council (APIC) in Barcelona, Spain in late October....

The Combination of GMP & Unapproved Drug Problems Continues to Prompt FDA Warning Letters

Warning letters to a pair of over-the-counter (OTC) drug manufacturers just released by FDA indicate that the marketing of unapproved drugs continues to escalate the agency’s response when GMP problems are found....
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