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Articles

The Democratic legislative proposal to authorize price negotiations on costly medicines covered by Medicare has drawn opposition from brand pharmaceutical and biotech companies.

Generics Makers Also Fight Price Controls

House and Senate leaders may have reached a compromise on a plan for controlling prices on select prescription drugs, but the industry continues to object.

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

FDA seeks to address the hurdles for incorporating real world data into submissions, while addressing concerns about relevance and reliability. 

FDA Acknowledges Hurdles in Utilizing Real World Data

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

FDA Highlights Value and Challenges of Advanced Drug Manufacturing

Rumor has it the White House will name cardiologist and research pro Robert Califf to the top FDA job, a position he held for nearly a year at the end of the Obama administration. But he may face opposition in the Senate.

Can Califf Bring Clarity and Enhanced Credibility to FDA?

New methods and policies necessitated by the global pandemic are slated to become permanent fixtures in FDA enforcement and regulatory programs.

Pandemic Alters FDA Inspections, Quality Oversight

Demand for more efficient development of medical products is prompting regulatory authorities to incorporate additional sources of information into research and approval processes.

FDA, Sponsors Advance Reliance on Real-World Data & Evidence

Critics say FDA is either acting too fast and risking public safety—or too slow—mired in rules while ignoring important scientific findings.

FDA Officials Caught in Political Crossfire

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

Biosimilars Gain Traction with Regulators and Manufacturers

If the debate over vaccines for adults and the need for extra booster shots has been heated, FDA will face even more scrutiny over the safety and value of vaccinating children under age 12.