Regulatory Blog

On 13 April 2022, the FDA's Office of Generic Drugs (OGD) published a draft manual of policies and procedures, (MAPP 5240.10) outlining...

On 11-March-2022, FDA released the final guidance "Providing Regulatory Submissions in Electronic and Non-Electronic 1 Format —...

This draft guidance document is being distributed for comment purposes only. Cybersecurity incidents have rendered medical devices and...

Yesterday USFDA published the fees for over-the-counter (OTC) monograph drugs for fiscal year (FY) 2022 in a Federal Register Notice...

FDA is issuing this draft guidance "Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs Guidance...

As a result of this guidance, the July 2013 draft guidance Pre-Launch Activities Importation Requests (PLAIR) has been finalized, which...

On 28-February-2022, the US Food and Drug Administration (FDA) finalized guidance to assist sponsors in collecting and submitting...

US Food and Drug Administration (FDA) issued draft guidance discussing formal meetings between sponsors of over-the-counter (OTC)...

US Food and Drug Administration (FDA) has finalized guidance for industry and agency staff on the use of Principles of Premarket Pathways...

This guidance is intended to assist applicants and holders of an abbreviated new drug application (ANDA) in updating their labeling...

US FDA issued two medical devices (final guidance documents on January 26, 2022, to help sponsors better incorporate and capture...

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

Yesterday U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Pfizer’s Paxlovid (nirmatrelvir tablets and...

Senior US Senator Chuck Grassley has urged to "reinstate unannounced" inspections of prescription drug manufacturing facilities in...

This guidance was developed within the Expert Working Group (Quality) of the International Council for Harmonisation of Technical...

This guidance provides recommendations to holders of biologics license applications (BLAs) for specified biological products regarding...

On December 2,2021 the U.S. (FDA) published the Fiscal Year (FY) 2022 Generic Drug User Fee Amendments (GDUFA) Science and Research...

Yesterday, the USFDA issued draft guidance for the industry titled Real-World Data: Assessing Registries to Support Regulatory...

The current challenges with the eCTD system that the agency currently uses, explaining how it does “not follow the development flow of...

This guidance document is intended to provide information regarding the recommended documentation sponsors should include in premarket...