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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
Impax received its second Form 483 in less than a week for a poor inspection of its U.S. manufacturing facility, igniting fresh doubts on the company’s plan to win approval of its Parkinson’s drug Rytary. Read More
It’s back to bench testing for a specialty drug company after the FDA rejected its new drug application for a combination drug and device pain treatment product. Read More