Daily1d
Gland Pharma gets USFDA EIR for Pashamylaram facility
Telangana: Gland Pharma has received Establishment Inspection Report (EIR) from the United States Food and Drug ...
GlobalData on MSN2d
Charles River and Akron link to integrate cytokines into cell therapy
The integration enables closed system processing, a significant step in automating platforms and protocols for cell therapies ...
The National Law Review2d
FDA Issues Request for Information on High-Protein Yogurt
FDA is seeking information from all interested parties to understand current manufacturing practices and ingredients used to ...
Gland Pharma facility in Hyderabad gets EIR from U.S. FDA
Gland Pharma receives EIR from US FDA for Dundigal facility, indicating closure of inspection with no major concerns.
JD Supra3d
FDA Issues Draft Guidances on AI in Medical Devices, Drug Development: What Manufacturers and Sponsors Need to Know
The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software ...
Centre asks MSME drugmakers to submit action plans on quality compliance in 3 months or risk closure
The Indian government wants micro, small, and medium drugmakers to meet WHO GMP standards by the end of 2025 or face shutdown ...
Centre steps up pace of generic drug stores; one Jan Aushadhi Kendra to be opened every two hours
The generic drugs are procured from Indian drug makers that are certified by the WHO for following good manufacturing ...
JD Supra5d
FDA Draft Guidance Addresses Management of Environmental Pathogen Hazards for Low-Moisture Ready-to-Eat Foods
On January 6, the U.S. Food and Drug Administration (FDA) issued long-awaited draft guidance regarding Establishing Sanitation Programs ...
Bengal maternal death highlights concerns surrounding handling of medicines
The laxity in enforcing regulatory norms is one of the key issues that need to be addressed to check such incidents, ...