Regulatory Blog

On 18th March, 2024 the U.S. Food and Drug Administration (FDA) the Center for Drug Evaluation and Research released the final guidance...

Today (09 June 2023) the USFDA's Center for Drug Evaluation and Research (CDER) released updated final guidance on "Assessing User Fees...

The United States Food & Drug Administration published the final guidance "Cover Letter Attachments for Controlled Correspondences and...

Starting from March 27, 2023, the FDA generic drug program will resume in-person face-to-face (FTF) meetings with the industry along with...

Yesterday (10 March 2023) released an updated word template that shall declare their worldwide registration status (WWRS) for all new...

Recently on 21-December-2022, U.S Food and Drug Administration announced the availability of a draft guidance for industry entitled...

Earlier today (o2-Dec-2022) U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER) released a revised draft...

Yesterday (October 21, 2022) USFDA Released multiple New draft guidelines providing guidance on topical generic drug product...

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

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

On April 13, 2022, FDA published new draft guidance for the industry entitled “Considerations for Waiver Requests for pH Adjusters in...

FDA published a series of guidances on January 26, 2022 focussing on Generic Drug Application Submissions, Labeling, and Review. These...

On 20.09.2021, USFDA released an updated Questions and Answers on Quality-Related Controlled Correspondence Guidance for Industry. This...