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tag open-protocol

FDA slammed over Aduhelm OK as Biogen takes heat for $56k price tag

pharmaphorum

JUNE 8, 2021

Phase 4 studies typically require less onerous protocols than phase 3 – for example they can use real-world evidence. The post FDA slammed over Aduhelm OK as Biogen takes heat for $56k price tag appeared first on. Though good luck taking the drug off the market if future data doesn't support the its efficacy.

Labelling

Labelling Drug Pricing

Equipment cleaning procedure in pharmaceutical, Do’s and Don’ts

GMPSOP

JULY 14, 2023

Equipment cleaning validation protocol was not discussed intensely in this article which was covered elsewhere in this blog. Equipment cleaning record and tag 240 SOPs, 197 GMP Manuals, 64 Templates, 30 Training modules, 167 Forms. With equipment, a tagging system should identify the equipment cleaning status.

Documentation

Documentation Labelling Pharmaceutical Manufacturing Packaging

FDA slammed over Aduhelm OK as Biogen takes heat for $56k price tag

Equipment cleaning procedure in pharmaceutical, Do’s and Don’ts

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