Regulatory Blog

USFDA's Center for Devices and Radiological Health released two updated, finalized guidelines yesterday and earlier today...

USFDA finalized and released four Guidelines yesterday (05 October 2022), in accordance with the time frames set forth in the Generic...

USFDA's Center for Devices and Radiological Health and Center for Biologics Evaluation and Research finalized and released four Medical...

Earlier today (03 October 2022) USFDA released two finalized guidelines "Review of Drug Master Files in Advance of Certain ANDA...

Earlier today (03-October-2022) USFDA's Center for Drug Evaluation and Research released an important CMC topic and final guidance "...

Yesterday (27-September, 2022) USFDA released revised guidance on "Policy for Coronavirus Disease-2019 Tests During the Public Health...

USFDA finalized and released Multiple Medical Devices Guideline earlier today (28 September 2022). 1. Guidance on: Clinical Performance...

A draft guidance was released on 23 September 2022 by the US Food and Drug Administration on the ethical considerations for including and...

This document was issued on September 22, 2022. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be...

Yesterday (22 September 2022) USFDA issued “Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act...

Recently USFDA released an updated "Electronic Common Technical Document (eCTD) Technical Conformance Guide" that revised some sections...

In yesterday's final rule, the U.S. Food and Drug Administration outlined (Unpublished version) the requirements for annual reports by...

Yesterday (13-September,2022) FDA published a new webpage to share the most recent research activities of the Center for Drug Evaluation...

Earlier today (08-September-2022) USFDA's Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research...

Earlier today on 8-September-2022, USFDA's Center for Drug Evaluation and Research, Office of New Drugs published two draft Labeling...

Yesterday 07-September-2022, USFDA's Center for Drug Evaluation and Research published a draft guideline "General Clinical Pharmacology...

This draft guidance is released today for Public comments and when finalized, this guidance will replace Charging for Investigational...

Today USFDA's Center for Devices and Radiological Health updated multiple guidances such as "Regulatory Requirements for Hearing Aid...

Today (August 2, 2022) FDA published draft guidance for the industry, “Electronic Submission of Expedited Safety Reports from IND-Exempt...

Multiple guidances were updated and released by the USFDA last week and had some important updates related to Drugs, Biologics, and...