PharmTech Talk

Top Priority for Califf Is Combatting Health Misinformation

August 04, 2022

Better clinical data are needed, as well as strategies for tackling opioid abuse, tobacco use, and food safety.

FDA Confirms Ongoing Reliance on Remote Inspection Methods

August 02, 2022

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.

FDA Continues to Grapple with Accelerated Approval Issues

July 26, 2022

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

FDA Regulation of Nonprescription Drugs in Spotlight

July 14, 2022

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

FDA Drug Regulation Challenged by Anti-Abortion Campaign

July 08, 2022

Some states look to block access to approved drugs.

Regulators Seek More Drug Effects Research Related to Pregnancy and Lactation

June 27, 2022

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 Leaders Seek to Build Public Trust in Science and Gain Support for Regulation

June 22, 2022

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

FDA User Fee Legislation Advances in Senate

June 17, 2022

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

Pharmacists and Manufacturers Rip PBM Practices

June 01, 2022

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

FDA Moves Forward with State Drug Import Plans

May 31, 2022

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