Bioequivalency Drugs FDA Approval Research 
The Pharma Data
FEBRUARY 1, 2021
Food and Drug Administration (FDA) has approved a new intramuscular (IM) injection route of administration for Plegridy ® ( peginterferon beta-1a ) for the treatment of relapsing forms of multiple sclerosis (MS). Related Articles: Plegridy (peginterferon beta-1a) FDA Approval History. CAMBRIDGE, Mass.,
Camargo
DECEMBER 13, 2021
Both the FDA’s Center for Drug Evaluation and Research (CDER) and its Center for Biologics Evaluation and Research (CBER) have regulatory responsibility for therapeutic biological products, which are subject to both the Federal Food, Drug and Cosmetic (FD & C) Act and the Public Health Service (PHS) Act.
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Delveinsight
FEBRUARY 5, 2021
Fortunately, there exists FDA-approved therapies and drugs that double the success rates of quitting. Smoking Cessation: What are the drugs available in the market? The USFDA’s Center for Drug Evaluation and Research regulates and ensures the safety and effectiveness of these products.
Worldwide Clinical Trials
MAY 30, 2024
These advancements have fostered increased focus from politicians, policymakers, and the investment communities backing academic and industry-sponsored research projects. Researchers established efficacy of edaravone in a 24 week, randomized, placebo-controlled double-blind study in 137 Japanese patients.
The Pharma Data
APRIL 11, 2023
Dose proportionality and bioequivalence studies demonstrate once-daily AUSTEDO XR is therapeutically equivalent to twice-daily AUSTEDO ® (deutetrabenazine) tablets The U.S. Bioequivalence and relative bioavailability were established between the once-daily and twice-daily tablet formulations, with no new safety findings emerging.
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