Compounding Pharmacies, Regulations and Therapies

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Compounding Pharmacies

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Therapies

Recon: Pfizer, BioNTech submit BLA for COVID vaccine; MHRA approves first drug under Project Orbis

The Pharma Data

MAY 7, 2021

International regulators and WHO call for wider public access to clinical data ( EMA ). EU regulator begins real-time review of GSK-Vir COVID-19 antibody drug ( Reuters ) ( Press ). After QSR Delays, ‘It’s Full-Steam Ahead With That Proposed Regulation,’ FDA’s Shuren Vows ( MedtechInsight ).

Vaccine

Vaccine Compounding Pharmacies Regulations Drugs

Article FDA Thank You In proposed rule, FDA offers up a (surprisingly sparse) list of drugs that present demonstrable compounding difficulties

Agency IQ

MARCH 25, 2024

In proposed rule, FDA offers up a (surprisingly sparse) list of drugs that present demonstrable compounding difficulties FDA yesterday released a long-awaited proposed rule on a list of drug products that present demonstrable difficulties for compounding. This formulation received seven yes votes, two no votes, and one abstention.

FDA

FDA Pharmacy Production Drugs

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

Agency IQ

FEBRUARY 15, 2024

We have tried to sort guidance documents by topic area.

FDA

FDA Science Biosimilars Production

Drug Discovery Digest

Recon: Pfizer, BioNTech submit BLA for COVID vaccine; MHRA approves first drug under Project Orbis

Article FDA Thank You In proposed rule, FDA offers up a (surprisingly sparse) list of drugs that present demonstrable compounding difficulties

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

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