PPR Announces Fall 2012 Risk Regulation Series
Three seminars will offer critical insights into regulation’s impact on business and society.
Proposition 37: Science, Law, and Consumer Protection
Californians will vote on whether to require the labeling of foods containing genetically modified products.
Patents, Patients, and Profits: Winners and Losers in Drug Patent Challenges
Challenges to branded drugs from generic firms have benefits and costs.
Member of Congress Documents “Loophole” for Medical Device Approval
Advocacy groups join Rep. Markey in calling for reform of FDA review process.
WTO Creates Roadblock to Administration’s Anti-Smoking Initiative
U.S. prohibition of flavored cigarettes violates international trade agreement.
Court Misapplies First Amendment to Strike Down FDA Cigarette Warning Labels
A district court judge invents strict scrutiny requirement for commercial speech.
A Pill Everyone Can Swallow
The FDA’s proposal to modernize generic drug approvals meets with broad support.
Senators Introduce Bipartisan Bill to Streamline Medical Device Approval
New bill would allow manufacturers of certain medical device to bypass elements of FDA’s existing process.
Controversy Surrounds HHS Contraception Mandate
President’s advisers signal willingness to “work with religious groups.”
FDA Submits User-Fee Recommendations to Congress
Agency recommends statutory language for imposing user fees on biosimilar drug manufacturers.