Regulatory Blog

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...

A draft guidance was released on 23 September 2022 by the US Food and Drug Administration on the ethical considerations for including and...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In yesterday's final rule, the U.S. Food and Drug Administration outlined (Unpublished version) the requirements for annual reports by...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...

This draft guidance is released today for Public comments and when finalized, this guidance will replace Charging for Investigational...

Friday the USFDA agency published a new web page to share the most recent FDA actions and activities related to complex generics, which...

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

On 22-July 2022, USFDA released multiple guidance among them one is "Failure to Respond to an ANDA Complete Response Letter Within the...

This updated guidance provides recommendations on an alternate electronic format for submissions covered under an exemption from or a...

Yesterday, FDA issued a Small Entity Compliance Guide to help small businesses comply with the final rule on importation of prescription...

The USFDA recently released draft guidance intended to help stakeholders develop, maintain, and implement risk management plans (RMPs) to...

FDA has issued the final guidance titled “Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication...