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Human Drugs

Drugs Prices Higher in U.S. than 3 Other Countries: GAO

A Government Accountability Office analysis says prices for 20 major prescription drugs were higher in the U.S. than in three other countries.

Medical Devices

Soliton 510(k) Cleared for Tattoo/Cellulite Device

FDA clears a Soliton special 510(k) for modifications to its Resonic device and its use for tattoo removal and cellulite treatment.

Human Drugs

FDA Should Require Better Cancer Drug Trial Representation: Study

Academic medical center researchers document gaps in demographic representation for older adults and black patients in cancer therapeutic pre- and pos...

Federal Register

Info Collection on User Fee Refund

Federal Register notice: FDA seeks comments on an information collection extension entitled Electronic User Fee Payment Request Forms Form FDA 3913 a...

Medical Devices

Pew: Restore FDA Oversight of Lab-developed Tests

Pew Charitable Trusts calls on HHS to reinstate FDAs authority to require premarket reviews for laboratory-developed tests.

Human Drugs

FDA Addressing TIRF REMS Recertification Concerns

FDA says it is working with manufacturers of transmucosal immediate-release fentanyl products to ease provider and pharmacy recertification in a modif...

Human Drugs

FDA Priority Review for Takeda Cancer Drug NDA

FDA grants priority review to a Takeda NDA for mobocertinib to treat some lung cancers.

Human Drugs

Amgen Agrees to Sotorasib Dosing Trial

Amgen agrees to an FDA-proposed post-marketing requirement to conduct a multi-center randomized clinical trial to compare the safety and efficacy of L...

Human Drugs

Analysis Hits National Academy cBHT Report

A Compounding Pharmacy Foundation-funded report says FDA should ignore a National Academies report on the safety and efficacy of compounded hormones.

Medical Devices

7 Topics Discussed at MDUFA 5 Reauthorization Meeting

The 3/17 MDUFA 5 reauthorization FDA/industry meeting covered seven topics summarized by the agency.