Regulatory Blog

The U.S. Food and Drug Administration (USFDA) yesterday (17 October, 2024) has issued two comprehensive Q&A guidance titled " Core...

U.S. Food and Drug Administration announced yesterday (17 October 2024) a final guidance , " Review of Drug Master Files in Advance of...

The U.S. Food and Drug Administration (USFDA) has issued comprehensive Q&A guidance titled " Electronic Systems, Electronic Records, and...

USFDA's Center for Devices and Radiological Health has released four final guidances about dental products, such as Dental Impression...

The USFDA's Center for Biologics Evaluation and Research (CBER) has released the final guidance document , titled “ An Acceptable...

This Friday (13 Septmeber, 2024) the USFDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research...

FDA's Center for Drug Evaluation and Research revised the final guidance last week titled " ANDA Submissions | Amendments to Abbreviated...

The USFDA  (U.S. Food and Drug Administration) Center for Devices and Radiological Health provides detailed final guidance " Appeal...

USFDA's Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) released a draft...

Earlier today (04 September, 2024) U.S. Food and Drug Administration's Center for Drug Evaluation and Research released the second...

The USFDA Center for Drug Evaluation and Research issued the final guidance today (03 September 2024) " Bioresearch Monitoring...

Yesterday the U.S. Food and Drug Administration (FDA) has released critical guidance documents to streamline the regulatory pathways for...

The U.S. Food and Drug Administration (FDA) has released a guidance document titled " Predetermined Change Control Plans for Medical...

The U.S. Food and Drug Administration (FDA) on August 19, 2024, published the guidance “ Product-Specific Guidance Meetings Between FDA...

Last Thursday (08 August 2024) the U.S. Food and Drug Administration (FDA) released final guidance aimed at " Optimizing the Dosage of...

Yesterday (02 August, 2024), the Food and Drug Administration (FDA) announced that the final guidance on M12 drug interactions was...

On July 31, 2024 the U.S. Food and Drug Administration (FDA) recently published in the Federal Register notice (FRN) the User Fee Rates...

On July 25, 2024, the U.S. Food and Drug Administration (FDA), through its Center for Drug Evaluation and Research (CDER), Center for...

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research released a final guidance titled "Providing...

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research, and Center for Biologics Evaluation and Research...