Standards/Regulations

Sep 01, 2017
By Pharmaceutical Technology Editors
A new collaboration between CDER and ORA will more fully integrate drug review programs with facility evaluations and inspections, in an effort to streamline drug reviews while strengthening manufacturing oversight.
Sep 01, 2017
By Pharmaceutical Technology Editors
FDA has put out an alert regarding the risks associated with using Keytruda in combination with other anti-cancer drugs based on interim results from two clinical trials that showed increased risk of death.
Sep 01, 2017
By Pharmaceutical Technology Editors
Experts noted that the mechanism of drug release for these products after an overdose could put patients at risk.
Aug 28, 2017
By Pharmaceutical Technology Editors
FDA issues a statement on new policy and enforcement steps to ensure proper oversight of stem cell therapies and regenerative medicine in the wake of two incidents involving unauthorized stem-cell treatment activity.
Aug 28, 2017
High-priority issues requiring immediate attention leave little time for Congress to consider drug access proposals that have limited bipartisan support.
Aug 24, 2017
By Pharmaceutical Technology Editors
The US Pharmacopeial Convention is hosting a variety of workshops in Autumn 2017 on a wide range of topics including continuing education, bioassays, and peptides.
Aug 23, 2017
By Pharmaceutical Technology Editors
FDA sent a warning letter to Bicooya Cosmetics Limited after inspectors found rodent feces at the company’s Zhejiang, China facility.
Aug 23, 2017
By Pharmaceutical Technology Editors
FDA has signed a confidentiality commitment with the European Commission and the European Medicines Agency that allows FDA to share confidential information with EU regulations.
Aug 21, 2017
By Pharmaceutical Technology Editors
The directors of FDA’s Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Devices and Radiological Health praised Congress’ reauthorization of user fee programs.
Aug 21, 2017
By Pharmaceutical Technology Editors
A meeting of the Pediatric Advisory Committee will advise on the use of prescription opioid medications containing hydrocodone or codeine in children’s cough medicine.
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