PharmTech Talk

FDA Caught in Abortion Battles

December 17, 2021

FDA has become embroiled in the debate over access to “chemical” or “medication” abortions through the prescribing and distribution of the abortifacient mifepristone.

Califf Gains Bipartisan Support for FDA Confirmation

December 16, 2021

General agreement that FDA needs a confirmed commissioner may speed Califf’s appointment.

Drug Costs Central Issue in Budget Battles

December 07, 2021

President Joe Biden highlighted how current proposals for curbing outlays on pharmaceuticals will help protect patients’ health and save the government billions.

New Cures 2.0 Legislation Advances Biomedical Research and Care

November 18, 2021

Leading legislators have launched the campaign to enact a second version of the 21st Century Cures Act.

Will Pharma Accept the Democrats’ Drug Pricing Deal or Continue to Fight Reform?

November 03, 2021

Democratic leaders in the House and Senate appear to have reached a compromise on a relatively modest plan for controlling prices on certain prescription drugs.

FDA Acknowledges Hurdles in Utilizing Real-World Data

October 28, 2021

FDA has worked to clarify how drug development can gain from tapping into information in health care systems and claims databases.

FDA Highlights Value and Challenges of Advanced Drug Manufacturing

October 21, 2021

FDA is expanding its Emerging Technology Program and providing more support for new drug applications that present advanced manufacturing technologies.

FDA to Rely on Real World Data and Evidence for Future Research and Market Approvals

October 01, 2021

FDA and EMA are looking to tap real-world data and real-world evidence more broadly to accelerate the research and market approval process.

FDA Caught in the Political Crossfire

September 27, 2021

The lack of a new permanent commissioner has hampered FDA in articulating future priorities and pushing back against miscommunications and outside complaints.

Biosimilars Gain Traction with Regulators and Manufacturers

September 27, 2021

Biosimilar approvals and the advance of biosimilar testing and production may lead to greater access to alternative therapies.