general regulatory

FDA Approves New Treatment for Moderate-to-Severe Eczema

On Tuesday, March 28th, the FDA announced the approval of Dupixent (dupilumab), an injection for the treatment of adults with moderate-to-severe atopic dermatitis. What is Atopic Dermatitis? Atopic...

510(k) Database Enables Sponsors to Search for Substantially Equivalent Medical Devices

Sponsors no longer have to rely on checking lists of 510(k) devices when looking to make a substantial equivalence claim. While the FDA does release an updated list each month, Sponsors can save time...

FDA to Hold Public Meeting to Discuss Patient-Focused Drug Development for Autism

On Monday, March 6th, the FDA announced plans to hold a public meeting regarding the development of patient-focused drugs for autism. In the notice published in the Federal Register, the FDA notes...

2016 was Record-Setting Year for Generic Drug Approvals, Reports FDA

In a recent post on the FDA Voice blog, the Agency reported that its generic drug program hit record highs in 2016. In the blog post, Kathleen “Cook” Uhl, M.D., Director of FDA’s Office of Generic...

Endo Pharmaceuticals Recalls Self-Injected Erectile Dysfunction Drug Due to Concerns Over Sterility

On Friday, February 24th, FDA issued a press release stating that Endo Pharmaceuticals Inc. is recalling one lot of Edex® (alprostadil for injection) 10 mcg. What is Edex? Edex is a prescription only...

Senators work to Reform FDA’s Medical Device Inspection Process with Bipartisan Bill

On Wednesday, February 15th, Senators Michael Bennet (D – CO) and Johnny Isakson (R – GA) introduced a bill to improve FDA’s medical device inspection process. If passed, the bill would amend the...

FDA’s CDER Updates the Purple Book

On Tuesday, February 21st, the FDA’s Center for Drug Evaluation and Research (CDER) announced the availability of an updated version of the Purple Book. What is the Purple Book? “The ‘Purple Book’...

FDA Responds to Citizen Petition & Publishes Revised BE Recommendations for Difluprednate

On Wednesday, February 15th, the FDA issued a revised draft guidance, entitled “Draft Guidance on Difluprednate.” regarding its bioequivalence recommendations for the product. In the revised...

#2: Labeling for Human Prescription Drug and Biological Products – Implementing the PLR Content and Format Requirements

In 2013, the FDA released a guidance entitled “Labeling for Human Prescription Drug and Biological Products – Implementing the PLR Content and Format Requirements.” This guidance was finalized after...

FDA Warns of Potential Risks with Fluid-Filled Intragastric Balloons

In the past two years, the FDA has approved two different types of intragastric balloon systems: Fluid-filled intragastric balloon systems, including the ReShape Integrated Dual Balloon System and...

Prev 5 6 7 8 9