The FDA Law Blog
APRIL 8, 2024
Department of Health and Human Services (HHS) recently published a White Paper on Policy Considerations to Prevent Drug Shortages and Mitigate Supply Chain Vulnerabilities in the United States —with input from several HHS stakeholders, including FDA, CMS, and the Administration for Strategic Preparedness and Response. By Kalie E.
ISPE
JULY 5, 2023
13 An FDA-authored paper indicating support for the implementation of CM using science- and risk-based approaches followed soon thereafter. In addition to the FDA, health authorities in Canada, Europe, Australia, Japan, Switzerland, and New Zealand have also approved applications with CM for the production of solid oral dosage forms.
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ISPE
JULY 6, 2023
For much of the pharmaceutical industry, batch manufacturing (BM) processes that have been relied upon for decades remain the preferred approach for most oral solid dosage (OSD) drug products. Office of Pharmaceutical Quality (OPQ) White Paper. March 2023. www.fda.gov/media/165775/download 7 US Food and Drug Administration.
ISPE
MARCH 29, 2023
Ultimately, the summary was not adopted during the QbD pilot, but was reintroduced in 2014 when a Pharmaceutical Research and Manufacturers of America (PhRMA) team prepared a white paper describing the content and format of an improved Module 2. CPP 26 GMP Compression tooling (PQS) CPP 2 IPC Tablet hardness (P.3.4)
ISPE
MARCH 29, 2023
Ultimately, the summary was not adopted during the QbD pilot, but was reintroduced in 2014 when a Pharmaceutical Research and Manufacturers of America (PhRMA) team prepared a white paper describing the content and format of an improved Module 2. CPP 26 GMP Compression tooling (PQS) CPP 2 IPC Tablet hardness (P.3.4)
ISPE
SEPTEMBER 11, 2023
POD is suitable for a wide range of products, including oral solid dosage forms, mAbs, and cell therapy. Review: Continuous Manufacturing of Small Molecule Solid Oral Dosage Forms.” EFPIA White Paper on CMC Development, Manufacture and Supply of Pandemic COVID-19 Therapies and Vaccines.” doi:10.1016/j.jbiotec.2015.06.388
Pharmaceutical Technology
FEBRUARY 17, 2023
In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage. The focus on identifying the ideal drug dosage is not new. What is drug dose optimisation?
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