Regulatory Blog

Today (04 August 2023) the United States Food & Drug Administration's Center for Biologics Evaluation and Research and Center for Drug...

This draft guidance document is being distributed for comment purposes only.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

Study Data Technical Conformance Guide provides specifications, recommendations, and general considerations on how to submit standardized...

On 8th September 2021, FDA issued this guidance to provide general recommendations to prospective applicants and applicants of...

The Center for Drug Evaluation and Research (CDER) has launched the voluntary Novel Excipient Review Pilot Program (Pilot Program), which...

On 30th August 2021, the Center for Devices and Radiological Health released 2 new draft guidance related to Premarket, 510(k). i.e.,...

On 25th August 2021, the Oncology Center of Excellence along with the Center for Drug Evaluation and Research released new draft guidance...

This guidance document is intended to provide a general description of FDA Export Certification to industry and foreign governments. This...

On August 20, 2021, FDA Center for Drug Evaluation and Research (CDER) published a revision to the draft guidance for industry...

The User Fee programs help the Food and Drug Administration (FDA) to fulfill its mission of protecting public health and accelerating...

On 12th August, 2021 the US Food and Drug Administration (FDA) announced the establishment of a public docket to solicit comments on...

US Food and Drug Administration (FDA) on 06-July-2021, finalized guidance on “Development and Submission of Near Infrared Analytical...

USFDA on 06-July-2021, finalized guidance on the use of metastasis-free survival (MFS) as an endpoint in clinical trials for...

FDA announced the availability of a final guidance for the industry entitled "Field Alert Report (FAR) Submission: Questions and...

The US Food and Drug Administration (FDA) yesterday (06-July-2021) finalized its guidance on the form and content requirements for unique...

This guidance provides recommendations for clinical trials designed to assess the adhesion performance of transdermal and topical...

The US Food and Drug Administration on 1st-July,2021 issued final guidance to assist sponsors in using alternate electronic formats for...

FDA issued final guidance on June 21, 2021 to aid applicants of certain licensed biological products to determine the appropriate...

This guidance and the technical specifications document it incorporates by reference describe the requirements for electronic submission...

Medical devices encompass a vast array of products with different technologies, product lifecycles, complexity, intended users, and...