Camargo

NOVEMBER 11, 2020

Presumably, Antares’ long-established 90-person urology sales force can achieve pull-thru of this drug product. Labeling regulations prohibit reminder ads for products with boxed warnings, which the FDA requires when a drug product has very serious risks. Co-Authors: Jenny Fielder. Manager of Regulatory Compliance.

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Development Bioequivalency Generic Drugs Production 242

Pharmaceutical Technology

OCTOBER 28, 2022

To demonstrate bioequivalence for a generic small molecule drug, a company must carry out a Phase I clinical trial in healthy individuals to ensure that the area under the curve and maximum plasma concentration for their drug is equivalent to that of the brand name drug.

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Bioequivalency Production Branding Contamination 130

FDA Law Blog

FEBRUARY 26, 2024

314.3 , codified in 2016, which defines strength as the “ total quantity of drug substance in mass or units of activity in a dosage unit or container closure” and/or “the concentration of the drug substance.” mg/mL) for liquid parenteral drug products. FDA explained that its bioequivalence regulations at 21 C.F.R.

Production 59

Production Bioequivalency Drugs Containment 59

Delveinsight

FEBRUARY 5, 2021

The USFDA’s Center for Drug Evaluation and Research regulates and ensures the safety and effectiveness of these products. Some of these approved products contain nicotine as an active ingredient, while others do not. Generics in the Market. Quitting smoking is an arduous, exhausting process. However, it is possible.

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Marketing FDA Approval Branding Production 52