February 26, 2024
Formal FDA Meetings for Sponsors or Applications of PDUFA Products
This article has been updated since its original February 28, 2017 publication. Since the introduction of the Prescription Drug User Fee Act (PDUFA) VII for fiscal years 2023 - 2027, the FDA...
March 29, 2022
FDA’s Expedited Programs Explained
In order to incentivize the development of therapies (drugs biologics) to fill unmet medical needs for treatment of serious conditions, the FDA has developed various programs to expedite drug...
March 22, 2022
FDA Issues Guidance on Certain Ophthalmic Products: Policy for Compliance with 21 CFR Part 4
The U.S. Food and Drug Administration today issued the guidance for industry, Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4. This guidance provides information to...
October 5, 2021
Four Benefits of Requesting an FDA Pre-IND Meeting
Although not required, a Pre-IND Meeting is a critical milestone, one that is highly recommended by the FDA. The goal of the meeting is to receive general agreement from FDA that your drug...
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...
March 15, 2019
FDA Announces Update to Nonproprietary Naming Convention for Biosimilar Products
On Thursday, March 7th, FDA published a revised draft guidance, updating its nonproprietary naming convention for biological products licensed under section 351 of the Public Health Service Act (PHS...
February 28, 2019
Draft Guidance: Requesting Nonbinding Feedback After an FDA Inspection of Your Medical Device Establishment
On Tuesday, February 19th, FDA published a draft guidance for medical device makers which identifies a process for companies to request nonbinding feedback on certain FDA Form 483 deficiencies noted...
February 22, 2019
FDA Warns Health Care Providers About the Development of Cancer After Breast Implants
On Wednesday, February 6th, FDA issued a letter to health care providers to increase the awareness of an association between all breast implants and Breast Implant Associated-Anaplastic Large Cell...
February 18, 2019
FDA Approves First Therapy for Rare Blood-Clotting Disorder
On Wednesday, February 6th, FDA approved the Cablivi®(caplacizumab-yhdp) injection, the first product approved in combination with plasma exchange and immunosuppression specifically for adults with...