2005, Biosimilars and Dosage - Pharmacist Digest

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2005

Biosimilars

Dosage

Patents: a necessary evil?

European Pharmaceutical Review

OCTOBER 19, 2022

2 Recently, the US Patent and Trademark Office (US PTO) reiterated the concern that patents have been “misused to inhibit and delay – for years and even decades – competition from generic drugs and biosimilars, denying Americans access to lower-cost drugs.” Patents are often described as the ‘lifeblood’ of pharmaceutical companies.

FDA’s Proposal to Remove Oral Phenylephrine from the OTC Monograph Isn’t a Surprise but What is Left “Over-the-Counter”?

FDA Law Blog: Biosimilars

NOVEMBER 11, 2024

As those of us of a certain age remember, prior to 2005/2006, pseudoephedrine was the decongestant of choice for OTC multi-symptom cold medicine. Then, Congress passed, and the President signed the Combat Methamphetamine Epidemic Act of 2005. a); OTC Monograph M012: § M012.20. a); OTC Monograph M012: § M012.20.

Pharmacy Management

Pharmacy Management Dosage Documentation

Patents: a necessary evil?

FDA’s Proposal to Remove Oral Phenylephrine from the OTC Monograph Isn’t a Surprise but What is Left “Over-the-Counter”?

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