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An FDA advisory panel yesterday recommended that the agency reject a new drug application (NDA) for the cancer drug Genasense, saying the clinical trial data submitted in support of the application did not offer substantial evidence of the drug’s efficacy.
Concerns over variations in the formulation, dosage and manufacturing processes of all exocrine pancreatic insufficiency drugs (PIDs) have prompted the FDA to require new marketing applications for such products.
Failing to comply with FDA GMPs can have serious financial ramifications for a pharmaceutical firm — a reality that needs to be reflected in the priorities and actions of drug manufacturers’ boardrooms, according to a compliance and quality management expert.
A new FDA proposal that would require drug labeling to include a toll-free number for consumers to report drug side effects could cost the drug manufacturing industry more than $3 million to implement.
The FDA has issued a warning letter to California-based drug repackaging firm PharmPak, after discovering that deficiencies in the firm’s repackaging process may have resulted in cross-contamination between penicillin and nonpenicillin products.
Acting FDA Commissioner Lester Crawford announced late last month that the agency won’t release its multicenter analysis of cGMPs until August, roughly two months later than previously planned.
Israel-based generic firm Teva Pharmaceutical is objecting to what it contends is pressure from U.S. trade officials that Israel adopt a 10-year data exclusivity period for drugs — a period twice as long as that in the U.S.
The FDA's Center for Biologics Evaluation and Research (CBER) plans this year to develop a template for reviewing proposed products, implement a formal training program for reviewers and create more opportunities for biotech firms and other stakeholders to provide input on efforts to enhance the development of new products.
Drugmakers — especially brand companies — have several options for minimizing the effects of changes in Rx drug importation policy on U.S. pharmaceutical prices, including gaining FDA and foreign-government cooperation in limiting the trade practice, according to a report from the Congressional Budget Office (CBO).