Topic
FDA Approval
198 published works
Litigation & Trial
Why Drug Companies Want The FDA To Stop Asking For Clinical Trials
Big Pharma is trying to ram two sweeping overhauls through Congress, the “21st Century Cures Act” and the “Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act.” (The latter is so…
Drug & Device Law
The FDA Tiptoes – and Congress Splashes Into – the 21st Century
By Bexis
Here are a couple of non-litigation related matters that we thought our readers need to know about. First, the FDA. We’ve pointed out before that the FDA’s “intended use” regulations for drugs…
Life Sciences Legal Update
House Easily Passes 21st Century Cures Legislation, Includes Significant FDA Reforms
By Kevin Madagan, Vicki Tankle
On July 10, 2015, the U.S. House of Representatives passed with an overwhelming majority (344-77), the 21st Century Cures bill (H.R. 6), a high-profile bipartisan bill intended to speed up…
Health Law Update
House Passes 21st Century Cures Act
On July 10, 2014, the U.S. House of Representatives overwhelmingly passed legislation intended to speed the approval of drugs and medical devices and increase funding for medical research. The central…
Health Law Update
Pharmacy Benefit Manager Group Opposes 21st Century Cures Act’s Cost Offset
By Lee H. Rosebush, Dena Kessler
The trade coalition representing pharmacy benefit managers is raising concerns about major bipartisan legislation aimed at streamlining the approval of new medicines and medical devices. However, the Pharmaceutical Care Management…
Drug & Device Law
IP/Unfair Comp. Case Applies Buckman
The very name “intellectual property law” suggests it’s not for us. There are episodes of The Simpsons that seem too complicated for our pretty little heads. Anything deemed “intellectual” scares…
Legal Profession Blog
FDA Violations Lead To Disbarment
An attorney convicted on her plea of guilty to misprision of felony in Virginia federal district court has filed a motion for consent disbarment in IllinoisAs part of that plea, Movant admitted…
Food Safety News
Senators Reintroduce Bill to Combat Antibiotic Overuse
By News Desk
On Monday, Senators Dianne Feinstein (D-CA) and Susan Collins (R-ME) reintroduced the Prevention of Antibiotic Resistance Act (PARA). The bill, previously introduced in June 2013, would require the Food and…
Life Sciences Legal Update
U.S. Congressional Committees Address Drug And Device Approval
By Lisa Baird
As mentioned on our Health Industry Washington Watch blog, committees in both the House of Representatives and Senate last week addressed the speed at which medical innovations are approved and…
Drug & Device Law
S.D. Texas Upholds Texas Presumption of Non-liability for FDA-approved Drugs and Rejects Failure to Update Claim
Today’s post comes from the non-Dechert side of the DDL blog. This week is the anniversary of the beginning of Facebook. The question of whether Zuckerberg et al. could successfully "monetize" that platform has…