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Regulatory Oversight FDA Approval Manufacturers

Robins Kaplan LLP

Generic Launches Second Quarter 2025

Robins Kaplan LLP on

This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications....more

Gardner Law

The Importance of a Clinical Trial Strategy

Gardner Law on

Developing a medical product, such as a medical device, comes with important milestones that can cause a project to sink or swim. One major milestone is amassing the clinical data needed to support pre-market submissions....more

American Conference Institute (ACI)

[Virtual Event] 36th Annual FDA Boot Camp - March 24th - 25th, 8:15 am - 1:45 pm EDT

ACI’s FDA Boot Camp returns in a completely interactive virtual format to help life sciences attorneys and executives to master the fundamentals of FDA Regulation... Gain essential working knowledge of core FDA concepts,...more

Wilson Sonsini Goodrich & Rosati

Microbes and Medical Foods: A Growing Area of Commercial Importance

The 2nd Annual Microbiome Movement conference, recently held in San Diego, California, highlighted the growing importance of microbes as the basis for various commercial products. Microbe-containing products regulated by the...more

Holland & Knight LLP

FDA Issues Warning Letter Regarding Unapproved Stem Cell Products

Holland & Knight LLP on

The U.S. Food and Drug Administration (FDA) issued a statement on Dec. 20, 2018, once again putting stem cell companies on notice about its intention to crack down on the marketing of unapproved stem cell products, and...more

Verrill

"Right to Try" Comes to the Federal Stage: What Stakeholders Should Do Now

Verrill on

On May 30, 2018, surrounded by patients directly impacted by tragic and intractable diseases, President Trump signed into law the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017...more

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