Compliance FDA Approval Generic Drugs 
Camargo
NOVEMBER 11, 2020
announced a collaboration to develop a companion diagnostic for Vitrakvi® (larotrectinib) NTRK (neurotrophic tropomyosin receptor kinase) inhibitor, approved in the U.S. In October, less than 18 months later, the FDA approved the companion test, which will allow physicians to better identify target eligible patients. Ken Phelps.
pharmaphorum
JUNE 3, 2021
The FDA approval of Alkermes’ new antipsychotic drug Lybalvi couldn’t have gone any better for the company, but it could still face a big challenge positioning the new drug in the highly genericised market. The post After FDA approval, Alkermes plans soft launch for antipsychotic Lybalvi appeared first on.
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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.
Pharma Marketing Network
FEBRUARY 27, 2025
The ability to target based on demographics, interests, location, and behavior makes PPC a game-changer for pharma brands promoting prescription drugs, disease awareness, and patient education resources. PPC provides the tools to navigate compliance while reaching the right audience effectively. How can PPC be optimized for better ROI?
Pharmacy Checkers
DECEMBER 12, 2019
The GAO’s preliminary analysis on inspections brings back into light what Katherine Eban so passionately – and dramatically – exposed in her book Bottle of Lies: The Inside Story of the Generic Drug Boom.” A majority of inspections resulted in findings of non-compliance. based inspectors who go overseas, 66 remained unfilled.
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.
Pharma Marketing Network
MARCH 12, 2025
Without precise targeting, ad spend can be wasted on irrelevant searches, reducing conversion rates and compliance effectiveness. But how do you balance compliance with visibility? Competition for High-Value Keywords Branded drug names and general medical terms attract intense competition. A mix of branded (e.g.,
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