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The pressure is on for API makers to submit higher quality Type II drug master files, or DMFs. FDA official says many US ANDA approvals are delayed by poor quality DMFs. A representative of the generic drug industry, however, contends that FDA is partially to blame for this problem by setting impractical expectations and an unrealistically high bar for DMFs.
Latest From Manufacturing
Trump administration briefing materials show that the pharmaceutical industry's complaints about FDA's quality metrics initiative are getting high-level attention.
US FDA hands Pfizer its second complete response letter for its proposed biosimilar to Epogen/Procrit, citing manufacturing compliance concerns at a legacy Hospira manufacturing facility in Kansas that was the target of a February warning letter. Issue “is not directly related to EPO itself,” Pfizer’s Salomon Azoulay says.
Sonar Products and Stratus Pharmaceutical must operate under the terms of a Justice Department consent decree after failing to correct microbiological contamination and other drug GMP problems FDA identified, or obtain FDA approval for dermatological drug products they were marketing.
A growing number of pharmaceutical manufacturers are using predictive stability models to accelerate stability testing of their products for a wide range of applications. Regulators worldwide are also starting to accept predictive stability studies in lieu of full stability data in approving new drugs.
The World Health Organization has prepared a draft list of documents and certificates that national regulatory authorities can rely on to verify compliance with the most relevant good practices in relation to medicinal products that underwent manufacturing and clinical trials at foreign sites. The proposed approach can reduce duplicate, and the frequency of, inspections.
Genentech overcame objections from US FDA quality reviewers to win approval of Ocrevus for multiple sclerosis by adding release and stability testing and committing to resolving process control issues, while suspending plans to accelerate post-approval manufacturing changes.
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