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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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Available for Preorder: The 2022 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers

Drug Channels

Pharmacies and Pharmacy Benefit Managers is a definitive, nonpartisan resource that includes the most current information about pharmacy dispensing channels, third-party payers, pharmacy benefit managers (PBMs), patients’ financial contributions, government regulations, and much more. Click to Enlarge]. d/b/a Drug Channels Institute.

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Available for Preorder: The 2023 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers

Drug Channels

Pharmacies and Pharmacy Benefit Managers is a definitive, nonpartisan resource that includes the most current information about pharmacy dispensing channels, third-party payers, pharmacy benefit managers (PBMs), patients’ financial contributions, government regulations, and much more. Copyright © 2006-2023 Pembroke Consulting, Inc.

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Radioligand therapy pipeline with in-license for compounds targeting Fibroblast Activation Protein (FAP)

The Pharma Data

In particular, our expectations regarding the FAP targeting agents, including FAPI-46 and FAPI-74,could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global (..)

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Federal Marijuana Rescheduling: States Get Ready

FDA Law Blog: Biosimilars

Governors, state cannabis regulators, law enforcement groups and local governments weighed in, as did marijuana advocates and opponents, marijuana industry associations, Members of Congress, federal law enforcement groups, healthcare and human rights groups, unions and trade associations, and private individuals. 21 U.S.C. §

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Draft Guidance on Biosimilars and Interchangeables Tries to Smooth Path for Post-Approval Changes

FDA Law Blog: Biosimilars

The top line from FDA for any cGMP-governed industry like these is always going to be that quality matters. Here again though, both the guidance and the regulations describe how a persuasive filing may have advantages for an applicant.

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DFS500 Amendments: What You Need to Know

Perficient: Drug Development

This blog was co-authored by Perficient Risk and Regulatory CoE Member: Alicia Lawrence Perficient’s Risk and Regulatory Center of Excellence (CoE) remains at the forefront of evolving financial rules and regulations, ensuring readiness to tackle emerging challenges and safeguard financial institutions and its customers.