Changes to FDA approval process needed to improve safety of high-risk medical devices

Main Point: Current system allows approval of modified devices without clinical data. Published in: Annals of Internal Medicine Study Further:

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Novel drugs with successful results against hepatitis C

US Food and Drug Administration (FDA) have recommended two drugs; simeprevir and sofosbuvir, for approval. These drugs will be taken

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FDA approves Fycompa to treat partial-onset seizures in epilepsy patients

U.S. Food and Drug Administration (FDA) has approved Fycompa (perampanel) tablets by Eisai Inc. for the treatment of partial onset

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J&J and Bayer have not gotten approval by FDA to market Xarelto as Blood thinner

U.S. Food and Drug Administration (FDA) has voted against the new use of the Johnson & Johnson (J&J) and Bayer’s

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FDA has approved Generic Boniva tablets for treatment and prevention of Osteoporosis

U.S. Food and Drug Administration (FDA) has approved the first Boniva generics (ibandronate)  for the treatment or prevention of Osteoporosis.

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FDA has completed programs for rapid review of generic drugs

The Food and Drug Administration (FDA) has completed its three user fee programs that would collect hundreds of millions of

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