July 12, 2021
Pedaling While Fixing a Flat: Conducting a Good FDA Meeting Under Bad Circumstances
Before using a significant risk medical device in a clinical study, Sponsors must first obtain FDA approval. Frequently, the request for an investigational device exemption (IDE) is disapproved, and...
August 22, 2019
Only 12% of Generic Drugs Reviewed Were Approved in the 1st Review Cycle, says GAO Report
On August 7th, the U.S. Government Accountability Office (GAO) published its report on generic drug applications. In the report, GAO comments on the number of products approved on the first review...
February 12, 2019
FDA Issues Draft Guidance to Advance Development of Combination Products
On Tuesday, February 5th, FDA published a draft guidance explaining the principles for premarket review of combination products, including how to determine which type of premarket submission is...
January 21, 2019
FDA Draft Guidance on Tentatively Approved ANDA Submissions
FDA Draft Guidance on Tentatively Approved ANDA Submissions: On Wednesday, January 16th, the FDA published its first draft guidance since the partial government shutdown took effect on December 22,...
December 17, 2018
FDA Takes Big Steps to Advance its Biosimilar Policy Framework
On Tuesday, December 11th, FDA made large strides to advance its biosimilar policy framework, including the release of four guidance documents and a proposed rule. Through these guidance documents,...
November 27, 2018
FDA Takes Steps to Promote Digital Tools for Prescription Drugs
On Tuesday, November 20th, FDA announced the establishment of a public docket to solicit comments and feedback on a proposed framework regarding the regulation of prescription drug-use-related...
Good Clinical Practice
November 2, 2018
FDA Seeks Feedback on Surrogate Endpoint Table
On December 13, 2016, the 21st Century Cures Act was signed into law with the intention of speeding FDA’s approval time for drugs and medical devices. When signed, the Cures Act increased FDA’s...
October 1, 2018
FDA Issues Final Guidance Regarding Content & Format Requirements for ANDA Submissions
On Tuesday, September 25th, the FDA issued a guidance document entitled “ANDA Submissions – Content and Format.” The document, initially issued as a draft guidance in June 2014, provides sponsors...
September 27, 2018
Good Review Management Principles & Practices, Part Two: Operational Principles
Details on the fundamental values outlined on FDA’s GRMP draft guidance are available in our preceding article, entitled “Good Review Management Principles & Practices, Part One: Fundamental Values"...