News & Analysis as of

FDA Releases Compounding Policy Documents

The U.S. Food and Drug Administration (FDA) has released five policy documents regarding compounded human drug products in connection with its continued implementation of the compounding provisions of the Drug Quality and...more

Drug Compounding: Manufacturing Standards Announced for Outsourcing Facilities

In late 2013, Congress passed the Drug Quality and Security Act (DQSA) in response to a deadly fungal meningitis outbreak linked to a sterile compounded injectable drug shipped across the country and responsible for more than...more

FDA Issues Two Draft Guidance Documents Relating to Internet and Social Media Use by Drug and Device Manufacturers

On June 17, 2014, the Food and Drug Administration (“FDA”) released two draft guidance documents related to manufacturer communications on the Internet and social media platforms. The two documents are (1) “Internet/Social...more

Patent fundamentals for researchers, manufacturers

Patent laws function much the same way no matter the technology at issue. But there are some aspects of patent law that affect particular industries in specific ways. My Thompson Coburn colleague Steve Ritchey looked at some...more

In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litigation (Fed. Cir. 2013)

On the first day of February, the Federal Circuit rejected Impax's efforts to get out from under a preliminary injunction in a case captioned In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litigation. ...more

Weeks Defies Years of Jurisprudence, Allowing Innovator Liability for Generic Drugs

Last week the Alabama Supreme Court adopted brand-name manufacturer liability for a generic drug sold by another company, becoming the first state supreme court to do so. Wyeth, Inc. v. Weeks, No. 1101397 (Ala. Jan. 11,...more

Stakeholders Call for Final Sunshine Act Rule

On January 14, 2013, a group of stakeholders, including the AARP and the AFL-CIO, urged the Obama Administration to issue the long-awaited final rule (the “Final Rule”) implementing the Physician Payments Sunshine Act (the...more

Stengel Tangles MDA Preemption: Ninth Circuit Decision Creates Split on Buckman Preemption of Post-Market Reporting Requirements

Last week the Ninth Circuit created a new state-law cause of action against medical device manufacturers: “failure to warn the FDA.” The en banc opinion in Stengel v. Medtronic Inc., __ F.3d __, 2013 WL 106144, 13 C.D.O.S....more

8 Results
|
View per page
Page: of 1