Argent BioPharma has started formal clinical supply of its EU-GMP cannabinoid-based active pharmaceutical ingredient (API) ...

The FDA has issued its much-anticipated final guidance on cybersecurity risk management in medical devices, effective June ...

New Delhi: The country’s top drug regulator, the Drugs Controller General of India (DCGI), has received about 1,000 applications from micro, small and medium enterprise (MSME) medicine ...

The pharmaceutical testing lab BRS Analytical Service recalled products used to relieve dry and irritated eyes after "deviations" were found in adhering to FDA safety regulations.

Compliance of Revised Schedule M guidelines has not been a major worry for large manufacturers who have been into exports, especially to the US, as they have been following US FDA specifications ...

According to the FDA's FY 2023 Annual Report, the agency conducted 2,953 inspections globally in fiscal year 2023, comprising 2,499 routine surveillance inspections and 454 for-cause inspections ...

In this Thought Leader article., Ian Johnston from Cytiva discusses challenges related to process development, scaling technology, regulatory approvals, and GMP guidelines.

Among these, Current Good Manufacturing Practice (CGMP) guidelines set by agencies such as the U.S. Food and Drug Administration (FDA) play a pivotal role. Pharmaceutical CGMP manufacturing ...

Revised GMP norms for small drug firms to be issued soon; to be effective December As part of the government's guidelines, which were announced in July 2023 and notified in December, drugmakers ...

Conducted in compliance with GMP guidelines, release testing ensures that every batch of a drug leaving the manufacturing facility is safe for consumption and effective for its intended use. The scope ...