Cosmetics Drugs FDA Approval Generic Drugs 
FDA Law Blog
SEPTEMBER 6, 2023
Farquhar — A drug manufacturer’s bad post-inspection grade from the U.S. Food and Drug Administration – labeled an “Official Action Indicated” classification – is generally devastating for the facility, not least because it can stall FDA approval of applications to market drugs manufactured at the facility.
FDA Law Blog
AUGUST 21, 2023
Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. Brand drugs, generic drugs, and medical devices alike have all been the target of state failure-to-warn litigation; in a recent case, OTC acetaminophen is the target.
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The Pharma Data
MARCH 15, 2022
Agency Supports Development of Complex Generic Drug-Device Combination Product to Improve Competition and Access to More Affordable Medicines. This complex generic drug-device combination product, which is a metered-dose inhaler, should not be used to treat acute asthma attacks. Today, the U.S.
FDA Law Blog
APRIL 30, 2021
Some of the bills introduced are related to a House Judiciary Antitrust Subcommittee hearing, titled “ Addressing Anticompetitive Conduct and Consolidation in Health Care Markets ,” while others found their way into the Bill Hopper because of a renewed interest in Congress to address drug prices (see a recent U.S.
FDA Law Blog
APRIL 30, 2021
Some of the bills introduced are related to a House Judiciary Antitrust Subcommittee hearing, titled “ Addressing Anticompetitive Conduct and Consolidation in Health Care Markets ,” while others found their way into the Bill Hopper because of a renewed interest in Congress to address drug prices (see a recent U.S.
FDA Law Blog
MARCH 13, 2024
Part 2 (“Part Deux”) investigated the PTO’s position and recent decisions on PTE applications for patents covering products approved—and then withdrawn years later—under the Federal Food, Drug, and Cosmetic Act’s Accelerated Approval provisions (and otherwise). 10,544,220 (October 24, 2023) Pursuant to 37 C.F.R.
FDA Law Blog
AUGUST 16, 2021
Koblitz — Meet the newest category of drug applications: the PANDA. Nonetheless, FDA has been calling them ANDAs and listing them in the Orange Book as ANDAs for years, but recent changes to the Orange Book have spurred some confusion.
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