FDA Commissioner to Meet with Indian Regulatory Authorities
In first official visit to India, FDA commissioner to discuss ongoing collaboration on drug programs.
FDA has announced that Commissioner Margaret A. Hamburg, MD will make her first official trip to India on Feb. 10-18 to further strengthen cooperation between the FDA and its Indian regulatory counterparts.
During the trip, which will include visits to Delhi, Cochin, and Mumbai, Hamburg will meet with Indian policy and government leaders involved in the regulation of medical and food products exported to the United States. Currently, India is the second largest provider of finished drug products and the eighth largest exporter of food products to the United States.
“The FDA’s ongoing engagement with our regulatory counterparts in India is critical to our ability to effectively promote the health and safety of American and Indian consumers,” said Commissioner Hamburg. “I look forward to enhancing our existing relationship and identifying additional opportunities for collaboration.”
The US and Indian food and drug officials share information on the conduct of clinical trials and address product safety issues that may have an impact on both American and Indian consumers. Commissioner Hamburg will also meet with industry leaders in India to discuss the importance of maintaining high-quality standards in producing goods to ensure consumers have access to safe products, FDA reports.
Source: FDA
Understanding the Variability in Bioburden Test Results in Biomanufacturing
May 7th 2025This article explores the impact of test volume, microbial distribution, and dilution errors on bioburden testing variability. It presents statistical approaches to estimate percentage error and discusses strategies to optimize microbial enumeration techniques in biopharmaceutical quality control.
Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing
May 7th 2025The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.
Intertek to Expand UK GMP Facility with 6000 Square Feet of Lab and Office Space
May 7th 2025The company said the expansion is in response to globally rising demand for inhaled biologics, which offer distinct advantages in route of administration, but can be challenging products for developers.
