Topic

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Articles

Is FDA approving too many new drugs and added indications too quickly based on surrogate endpoints that fail to pan out? 

FDA Reviews Gains and Risks of Accelerated Approval Process

The Federal Trade Commission is launching a broad review of drug-company mergers, with an eye to examining how such actions can harm competition in the biopharmaceutical industry. 

FTC Eyes Crackdown on Pharma Mergers

With no final nomination of FDA commissioner coming from the White House, concern has mounted among regulated industry and interested stakeholders that FDA operations and stature will suffer without a permanent commissioner able to articulate new policies and gain support for innovative programs.

Where’s FDA’s Permanent Commissioner?

Reviews of FDA initiatives and activities recapitulate efforts to assess and approve new drugs, generic drugs, and biologics and strategies for advancing new initiatives.

FDA Documents Achievements and Plans for Future

To prevent future production delays of critical products, the Biden administration is examining supply chain vulnerabilities for pharmaceutical ingredients as part of a longer-range consideration of products important to public health. 

COVID-19 Vaccine Makers Overcome Challenges to Ramp Up Production

FDA issued a public statement and press release, along with a sharp warning letter rebuking AcelRx Pharmaceuticals for its messaging on painkiller Dsuvia.

FDA Blasts Misleading Opioid Promotion

Scientists and policy makers are looking more sharply at the lag in identifying and producing medicines to moderate early infections and to treat seriously ill patients. 

Where Are the Therapeutics to Combat COVID-19?

The selection of a new FDA commissioner has become a contentious issue in Washington, as the White House delays a decision and interest groups line up behind competing candidates. 

New Leadership for FDA Entangled in Politics

FDA puts applications on hold as the agency limits alternative oversight methods. 

FDA Inspection Shutdown Increasingly Delays Approvals

With Democrats controlling Congress and the White House, expectations are high that policy makers will revise certain coverage and payment policies. 

PharmTech Talk