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.
These featured panels at DeviceTalks Boston will explore the state of R&D at major medtech firms, as well as the latest trends when it comes to developing combination products, neuromodulation devices, robotic systems and women's health technology.
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