Alta Sciences

DECEMBER 14, 2023

A Closer Look At Our On-Site Compounding Pharmacies shajjar Thu, 12/14/2023 - 21:30 HTML Altasciences' dedicated pharmacists bring a wealth of expertise in controlled substances and complex compounding, ensuring maximum precision and safety standards. Electronic security access to the pharmacy and video monitoring. -

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Compounding Pharmacies Pharmacy Clinical Pharmacology Clinical Supply 40

Agency IQ

MARCH 25, 2024

FDA addressed the expanding practice of drug compounding in 1992 by issuing a compliance policy guide that clarified that pharmacies which compounded products at certain scales, for certain purposes, or without FDA approval were clearly operating “outside the bounds of traditional pharmacy practice.”

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The Pharma Data

MAY 7, 2021

Goldman Sachs jumps aboard Bain-backed 503(b) compounding pharmacy with a $275M debt loan to supply hospitals ( Endpoints ). Quest Pharmaceuticals Loses In Opioid Liability Coverage Suit ( Law360 ). Quest Pharmaceuticals Loses In Opioid Liability Coverage Suit ( Law360 ).

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Vaccine Compounding Pharmacies Regulations Drugs 52

Agency IQ

FEBRUARY 15, 2024

CDRH FY2024 Guidance Agenda Clinical application Recommendations for Investigational and Licensed COVID-19 Convalescent Plasma CBER Final By 12/31/24 CBER CY 2024 Guidance Agenda Blood Considerations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method CBER Draft (..)

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FDA Science Biosimilars Clinical Trials 40

Agency IQ

AUGUST 25, 2023

The potential for Congress to overturn this dynamic could have major and negative effects on the drug’s current owner, Jazz Pharmaceuticals. For example, Epidiolex at present is effectively protected by provisions of DSHEA which limit the introduction of CBD as a legally regulated product due to its status as an approved drug.

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Regulations FDA Science Production 40