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The new rule establishing FDA powers to destroy suspected counterfeit and adulterated drugs could cause shortages if the agency doesn’t protect against officials destroying needed excipients that get caught up in an import dispute, according to PhRMA. Read More
Over the next five years the FDA plans to increasingly coordinate its inspections and enforcement activities with its international counterparts. Read More
The FDA intends to step up its scrutiny of a company’s data integrity protections during manufacturing inspections, following a series of investigations that caught drugmakers backdating manufacturing records and falsifying data. Read More
The FDA will grant marketing exclusivity only to biologics that are fundamentally different from existing products, according to a new guidance that explains what manufacturers must do to lock in protection from biosmiliar competition. Read More
Two industry groups in India are suing the country’s drug regulatory authority for enacting price controls on scores of branded-generic drugs to treat diabetes and cardiovascular disorders. Read More
Drugs launched after Congress passed legislation to accelerate the approval process are more likely to be given safety warnings or pulled from the market altogether, according to a new study critical of the FDA’s current review process. Read More
The National Institutes of Health is talking with drugmakers about the potential of scaling up production of an experimental recombinant Ebola vaccine set to enter human testing next month. Read More
The European Medicines Agency is seeking suggestions on promising techniques to identify genomic biomarkers that might spur development of targeted therapies. Read More