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.
FDA Warns Patients of Stem Cell Scams
The FDA cautions patients to undergo only approved stem cell treatments.
Regulatory Conference Discusses Oversight of Laboratory Developed Tests
Regulatory conference highlights need for defined governance of laboratory developed diagnostic testing.