Tech Talk

FDA’s hybrid inspection model will remain a regular means for supplementing onsite inspections and will be further integrated into the agency’s oversight operations.

Scrutiny of accelerated approvals has generated a range of reform proposals to accelerate the conduct of confirmatory studies.

Application for OTC contraceptive highlights efforts to broaden access to medicines.

Some states look to block access to approved drugs.

Regulators wish to expand and clarify methods for obtaining information on medicines used by or needed for pregnant and lactating individuals through clinical trials and postapproval studies.

FDA is at a pivotal moment because of important gains in medical treatment based on science.

Measure tackles infant formula, cosmetics, diagnostics plus drug development and access.

Manufacturers are aligning with pharmacists and providers to blame high drug costs and limited patient access on pharmacy benefit managers.

FDA once again is taking steps to facilitate the import of less costly prescription drugs.

Issues related to mifepristone prescribing and dispensing are emerging in the debate over legislation to reauthorize FDA user fees for drugs and medical products.

Members of Congress asked FDA about multiple contentious issues, including expedited approvals, vaccines for young children, orphan drug exclusivity, access to medical abortions, conflicts of interest, and hiring initiatives.

New guidance from FDA and legislation from Congress promote clinical trial diversity.

FDA is reviving efforts to establish a Quality Management Maturity program.

Democrats have proposed a measure to facilitate access to less costly comparator drugs needed in clinical trials, while another bill aims to increase transparency in the costs of clinical trials.

Legislative proposals set the stage for debate on FDA policies and programs and whether to include some measures in legislation to reauthorize user fees.

Consumer advocates continue to press for initiatives to lower drug prices by revising or reducing patent protections.

Congress is considering revising and improving policies related to drug development and regulation for possible inclusion in broader legislation to reauthorize FDA user fees.

The US Congress approved a federal spending package that increases funding for a range of programs to advance health and medicine.

Biotech companies and medical product manufacturers have condemned the invasion of Ukraine, while also looking to maintain supplies of essential medicines.

Califf will face challenges that include COVID-19, opioids, and user fees.

FDA officials and their scientific advisors have come down hard on clinical development programs that rely on study results from a single foreign country, instead of from multi-regional trials following harmonized R&D standards.

With new COVID-19 infections declining, the agency is resuming domestic inspections of drug manufacturing facilities.

A range of political issues have impacted FDA initiatives vital to the agency’s effectiveness and stature, both at home and on the important global stage.

The draft PREVENT Pandemic Act aims to secure supply chains, expand health data collection, and support access to vital medical products

Delays in sponsors providing postapproval evidence of effectiveness for therapies benefitting from streamlined FDA regulatory pathways are generating pressure for further review and reform of the agency’s accelerated approval process.

The Centers for Medicare and Medicaid Services took action to limit prescribing and use of Biogen’s new and controversial Alzheimer’s treatment Aduhelm (aducanumab).

FDA maintained a steady pace in 2021 in approving important new therapies for market, including new vaccines and treatments for COVID-19.

FDA authorized emergency use of Pfizer’s oral antiviral drug to make the drug available as quickly as possible.