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October 3, 2022

FDA Approves Futibatinib for Certain Biliary Tract Cancers FDA Approves Futibatinib for Certain Biliary Tract Cancers

The US Food and Drug Administration (FDA) has granted an accelerated approval for a new drug, futibatinib (Lytgobi), to be used for patients with a certain […]
October 3, 2022

Ruxolitinib Repigments Many Vitiligo Affected Body Areas Ruxolitinib Repigments Many Vitiligo Affected Body Areas

Ruxolitinib (Opzelura) cream can help repigment the skin in many body areas affected with vitiligo, researchers reported at the European Academy of Dermatology and Venereology (EADV) […]
October 3, 2022

Gardasil 9 HPV Vaccine Advised for MSM Living With HIV Gardasil 9 HPV Vaccine Advised for MSM Living With HIV

Men who have sex with men (MSM) living with HIV, especially those who are young or who’ve had gonorrhea should get the human papillomavirus (HPV) 9-valent […]
October 3, 2022

Balanced Fat Intake Links With Less Type 2 Diabetes Balanced Fat Intake Links With Less Type 2 Diabetes

Researchers published the study covered in this summary on Preprints with The Lancet as a preprint that has not yet been peer reviewed. Key Takeaways Adults […]
October 3, 2022

GDUFA III Reauthorization

Generic drug user fees make it possible for FDA and industry to continue to ensure that the American public has access to safe, effective and high-quality […]
October 3, 2022

GDUFA II Drug Master Files (DMFs)

What’s New GDUFA III enhancements for Type II API DMFs start on 10/1/2022 Drug master files (DMFs) are submissions to FDA used to provide confidential, detailed […]
October 3, 2022

Rare Disease Endpoint Advancement Pilot Program Frequently Asked Questions

Q: What is the Rare Disease Endpoint Advancement (RDEA) pilot program? A: The RDEA Pilot Program is a U.S. Food and Drug Administration pilot meeting program, […]
October 3, 2022

GDUFA III User Fee Resource Management Program

To promote accountability and transparency, GDUFA III includes provisions so that industry and public stakeholders are able to observe how the Agency’s fee revenues are being utilized.  Financial Reports   […]
October 3, 2022

GDUFA III Drug Master File (DMF) Review Enhancements

Effective communication among ANDA applicants, DMF holders, and FDA is essential for reducing the likelihood of potential problems that could delay approvals. The reauthorization of the […]
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