Search


USFDA Guidance: An Acceptable Circular of Information for the Use of Human Blood and Blood Components
The USFDA's Center for Biologics Evaluation and Research (CBER) has released the final guidance document , titled “ An Acceptable...

Sharan Murugan
Sep 25, 20242 min read
Â
Â


USFDA Guidance: Considerations for the Use of Human-and Animal-Derived Materials & Recognition and Use of a Standard for Uniform Blood & Blood Component Container Labels
Yesterday (30 April 2024), the FDA released a draft guidance for the industry titled "Considerations for the Use of Human-and...

Sharan Murugan
May 1, 20242 min read
Â
Â


Saudi's SFDA: Good Manufacturing Practice for Blood Establishments
Blood establishments play a crucial role in ensuring a safe and adequate supply of blood for transfusion and other medical purposes. To...

Sharan Murugan
Feb 7, 20242 min read
Â
Â


USFDA Guidance: Policy for Testing of Alcohol & Developing Drugs for DFI Treatment
Earlier today (17 October 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research and Center for...

Sharan Murugan
Oct 17, 20232 min read
Â
Â


USFDA Guidance: Testing of Glycerin & High Risk Drug Components & CBER Guidances on Blood Products
This week (11 & 12 May 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research and Center for...

Sharan Murugan
May 13, 20231 min read
Â
Â


USFDA's recent Guidance on Biologics: Ophthalmic Products & Development of (CAR) T Cell Products
1. Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR This guidance is intended to provide information to applicants...

Sharan Murugan
Mar 23, 20221 min read
Â
Â
