Compounding Pharmacies, Pharmaceuticals and Therapies

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Compounding Pharmacies

Pharmaceuticals

Therapies

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

Requirements for 503A pharmacies have since been updated, most notably under the Drug Quality and Security Act ( DQSA ) of 2013, which established new requirements for 503A pharmacies as well as a new category of compounding pharmacies, known as outsourcing facilities (503B pharmacies). suppositories).

FDA

FDA Pharmacy Production Drugs

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

The Pharma Data

MAY 7, 2021

Catalent snaps up Promethera’s cell therapy subsidiary, complete with a Belgian plant to help scale plasmid DNA efforts ( Endpoints ). Goldman Sachs jumps aboard Bain-backed 503(b) compounding pharmacy with a $275M debt loan to supply hospitals ( Endpoints ). . Pharma & Biotech.

Vaccine

Vaccine Compounding Pharmacies Regulations 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 Clinical Trials

Drug Discovery Digest

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

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

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

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