To prove a generic drug is as safe and effective as the branded version, pharmaceutical companies have to hand over upwards of 1,000 doses of the product to a generic developer.
But if the manufacturer creating the generic drug cannot get its hands on enough sample, the development and testing process slows down. It could potentially even keep a generic version of the drug from ever reaching the market.
If companies developing generics have trouble accessing the samples they need, they can file a complaint with the FDA. Today, the FDA published a list of 39 pharmaceutical companies that have been the subjects of such complaints.
Get the full story at our sister site, Drug Delivery Business News.
