"The DEA is creating a regulatory paradox where science is stifled and illegal activity is tolerated. Thomas Prevoznik, one unelected bureaucrat should not have the power to derail federally authorize ...

Not to be released, published, distributed or circulated in any jurisdiction in which it would be unlawful to do so. This press release is for information purposes only and does not constitute an offe ...

Zhong Li’s extensive history with the FDA offers crucial lessons on how companies in the pharmaceutical and biopharmaceutical sectors should approach inspection preparedness.  As an experienced FDA ...

FDA inspections are essential to ensuring the safety and quality of products in the food, pharmaceutical, and medical device industries. One of the experienced professionals in this field is John ...

As the NMPA joins the EU and the U.S. in placing sterility assurance and contamination control front and center, ...

On May 6, the US Food and Drug Administration (FDA) announced plans to expand its use of unannounced inspections at foreign manufacturing ...

The inspection was a systems & processes audit resulting in the site approval for all studies conducted at QPS India and submitted by sponsors for US regulatory agency approval. This approval ...

Dr. Reddy's Laboratories faced USFDA scrutiny at its New York API facility, receiving a Form 483 with two observations after ...

The Department of Health and Human Services May 13 announced ( a 60-day public comment period opened for stakeholders ...

The Windsor Framework marks a significant change in the UK's post-Brexit regulatory space, particularly for the pharmaceutical sector. By addressing the complexities of the Northern Ireland ...

The Federal Antimonopoly Service has launched unscheduled anti-cartel inspections of a number of pharmaceutical companies. This is reported on the FAS website., JSC "Protek Implementation Center", JSC ...

HYDERABAD: Pharma major Dr Reddy’s Laboratories on Saturday said its active pharmaceutical ingredients manufacturing facility ...