Hamburg Describes Efforts to Develop Medical Countermeasures

At a conference on preserving national security at the University of Pittsburgh Medical Center last week, FDA Commissioner Margaret Hamburg stressed the importance of medical countermeasures for responding to natural and deliberate threats to public health.

FDA Sends sanofi aventis Two Warning Letters

FDA recently sent sanofi-aventis two Warning Letters for its facilities in Frankfurt am Main, Germany, and Bridgewater, NJ.

sanofi aventis Buys Genzyme

Last Wednesday, sanofi aventis agreed to acquire Genzyme for $74 per share in cash, or approximately $20.1 billion.

Senate Bill Would Mitigate Drug Shortages

US Senators Amy Klobuchar (D-MN) and Bob Casey (D-PA) introduced the "Preserving Access to Life-Saving Medications Act," which is intended to help address and prevent shortages of prescription drug medications.

Manufacturers Recalibrate Microbial Control for Nonsterile Drugs

Developments during the past several years have led many industry professionals to question whether nonsterile dosage forms are being produced in a state of control.

Lethal Injections and Foreign Inspections

Senate to Consider Patent-Reform Bill

Last Thursday, the US Senate scheduled the Patent Reform Act of 2011 for debate after the Senate Judiciary Committee passed the bill.

Senators Reintroduce Bill to Curb Pay-for-Delay Settlements

Last Friday, Senators Herb Kohl (D-WI) and Chuck Grassley (R-IA) reintroduced their "Preserve Access to Affordable Generics Act," which would presume that pay-for-delay settlements were illegal and give the Federal Trade Commission (FTC) the power to block them.

FDA Publishes Revised Process-Validation Guidance

FDA published its long-awaited guidance titled Process Validation: General Principles and Practices this week.