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.
Regulatory Year in Review: 2011
Health care reform, the Dodd-Frank Act, environmental protection, and open government are discussed in our top news posts from 2011.
Bipartisan Bill Would Relax FDA Conflict-of-Interest Policies
Legislation seeks to speed FDA review of medical products.
FDA and NABP Mobilize to Confront the Online Sale of Illegal Drugs
Governmental and nongovernmental action taken to discourage illegal pharmaceutical sales over the Internet.
FDA Announces “Network of Experts” Pilot Program
“Network of Experts” intended to give FDA quicker information on emerging medical devices.
DEA Plans Ban on “Bath Salts” and “Plant Food”
Agency intends to prohibit the sale of synthetic stimulants, at least temporarily.
PPR Hosts Conference on U.S. Regulation Crisis
Leading scholars analyze whether regulation has suffered a breakdown.