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Schedule III Marijuana Would Still Be Regulated Marijuana

FDA Law Blog: Biosimilars

Dispensing marijuana to patients, as required for other schedule III substances, would require a prescription issued for legitimate medical purpose by a DEA-registered and state licensed practitioner. Marijuana down-rescheduled to schedule III would still be regulated for legitimate medical, scientific and industrial use.

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What to Expect When you are Expecting…a Government Shutdown

FDA Law Blog: Biosimilars

The question that is always on the mind of folks in FDA-regulated industries is, what does that mean for my application/inspection/meeting? For pre-license or pre-approval inspections, the outcome of a shutdown is less draconian as these are under the auspices of a user-fee program.

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Draft Guidance on Biosimilars and Interchangeables Tries to Smooth Path for Post-Approval Changes

FDA Law Blog: Biosimilars

In areas like biologics, biosimilars, and interchangeable biosimilars, where emerging technologies meet regulatory complexities, this is perhaps a wise strategy. But in the biologics and biosimilar industries, maintaining quality can be a very nuanced—if not difficult—process.

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Teva and Bioeq Announce Commercial Partnership for Biosimilar

The Pharma Data

Agreement includes commercializing biosimilar candidate of ophthalmology drug ranibizumab (Lucentis ® ) in Europe, Canada, Israel and global markets. Bioeq has in-licensed the exclusive global commercialization rights to FYB201 from the German biosimilar developer Formycon AG. Source link: [link].

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Replimune drug rejected by FDA; Omega raises $647M biotech fund

BioPharma Drive: Drug Pricing

Published July 22, 2025 By BioPharma Dive staff post share post print email license Daniel Tadevosyan via Getty Images Today, a brief rundown of news involving Replimune Group and Johnson & Johnson, as well as updates from Omega Funds, iTeos Therapeutics and Roche that you may have missed. and European life sciences companies.

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Hyman, Phelps & McNamara, P.C. (HP&M) is Pleased to Announce the Addition of Sara M. Keup as the new State Licensing Regulatory Expert for the Firm’s Licensing Practice

FDA Law Blog: Biosimilars

HP&M has been helping clients navigate the challenges of state licensing regulations for drugs, biologics, medical devices, OTCs, 503B outsourcing facilities, 503A pharmacies, foods, dietary supplements, cannabis, and wholesalers/distributors for many years. Keup has joined the firm to assist attorneys Karla L.

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FDA’s Revised Draft Guidance on Biological Product Promotion Provides Additional Recommendations/Clarifications

FDA Law Blog: Biosimilars

This Revised Draft Guidance provides considerations for manufacturers, packers or distributors (dubbed “firms”) of prescription biological reference products, biosimilar products, and interchangeable biosimilar products presenting data and information about such products in promotional materials in a truthful and non-misleading way.