Regulatory Sciences
Compiling and submitting a New Drug Application (NDA) submission is a complicated and intensive activity. Once you have submitted your application to FDA, you may be curious about what can you expect...
Guidance Document August 2022 This guidance provides instructions for the electronic submission of expedited individual case safety reports (ICSRs) from investigational new drug (IND)-exempt...
The Good Clinical Practice (GCP) Inspectors Working Group has developed procedures for the coordination, preparation, conduct and reporting of GCP inspections requested by the European Medicines...
FDA has issued the final guidance titled “Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors.” The recommendations for prescription drug and...
Guidance for Industry May 2022 Today, FDA is announcing revisions to the 2006 guidance “Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production.” Specifically, this...
On Wednesday, September 29th, EMA announced the implementation of new measures indented to replace, reduce, and refine animal use in the development, manufacturing, and testing of human and...
On Thursday, March 7th, FDA published a revised draft guidance, updating its nonproprietary naming convention for biological products licensed under section 351 of the Public Health Service Act (PHS...
Earlier this month, FDA announced the approval of Spravato (esketamine) nasal spray. The product is to be used in conjunction with an oral antidepressant and is indicated for the treatment of...
On Tuesday, February 5th, FDA published a draft guidance explaining the principles for premarket review of combination products, including how to determine which type of premarket submission is...
On Wednesday, January 16th, the FDA published its first draft guidance since the partial government shutdown took effect on December 22, 2018. The draft guidance, entitled "ANDA Submissions –...