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The FDA’s Office of Regulatory Affairs officially began its transition to a program-based structure, aligning inspection staff into seven product categories — more closely mirroring the organization of the agency’s centers. Read More
An FDA investigation into serous quality problems at a Florida pharmaceutical company revealed a litany of unsound practices in the manufacture of experimental drugs. Read More
The PTO’s Patent Trial and Appeal Board invalidated a patent for AbbVie’s flagship drug Humira, saying its claims were unpatentable following a challenge by Coherus Biosciences. Read More
HHS has once again pushed back the effective date of its final rule instituting fines for drugmakers that overcharge for products under the 340B drug discount program. Read More
A bill to reauthorize FDA user fees for the next five years received voice-vote approval from a House health subcommittee Thursday. The measure now heads to the full Energy and Commerce Committee for consideration. Read More