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FDA

FDA Will Not Pull Teva And MSN Hetlioz ANDAs, Finds No ‘Serious Discrepancies’

The FDA has concluded that generic tasimelteon products held by Teva and MSN Labs meet all statutory bioequivalence requirements, and that there was no “mistake” or untrue statement in the original ANDA approvals, as it denied Vanda’s citizen petition.

US FDA’s Tough Talk On Talc: Regulating In An Echo Chamber

An FDA “expert roundtable” on talc produced a new talking point on a potential drug safety risk, but the basis of that claim is difficult to determine.

Biotech Investor, One-Time US FDA Commissioner Candidate Returns To HHS As RFK Jr.’s Top Deputy

Jim O’Neill recently was CEO of age-related diseases group SENS Research Foundation. After serving in HHS from 2002 to 2008, he became a managing director of Clarium Capital global investment fund and was Thiel Foundation CEO, funding nonprofits that promote technology.

US FDA Has Lists To Assure Progress On Supplement Sector Regulations, NDIN Guidance

The agency says items on its Human Foods Program’s proposed agenda for guidance “to complete during 2025” include identity and safety information for NDI notifications. Its announcement also links to document about a separate key industry question, a rulemaking which would recognize NAC as a lawful

Removal Of REMS For CAR-Ts Could Greatly Expand Their Reach

The FDA eliminated REMS requirements for approved CAR-T cell therapies that have limited their availability, a move that could enable increased use in the community setting.

Utah Delegation’s Support For Supplement Industry Key For Caucus Restart In Congress

Dietary Supplement Caucus e-launched the 119th Congress with Utah Republican House member Mike Kennedy and Texas Democrat member Marc Veasey as co-chairs and with a total of nine senators and 20 House members spanning both parties.

US Adverse Event Report Forms Replace ‘Gender’ Options With Male Or Female ‘Sex’ Question

Modifications to forms FDA 3500, for voluntary reporting by healthcare professionals, and 3500A, for mandatory reporting by manufacturers, marketers or facilities, include limiting changing gender question to sex and asking for only male or female answer.

Paying User Fees Not A Priority For Many OTC Monograph Drug Firms, First Arrears List Shows

The 1,383 entries on OMUFA arrears list for facility registrations from FY2021 through FY2025 on FDA’s list exceeds its estimate of 1,134 entities subject to the fee for FY2025.

Gilead’s Yeztugo Gets US Approval For Twice-Yearly PrEP

The first twice-yearly option for HIV prevention has been approved by the US Food and Drug Administration in an advance that “brings us closer than ever to ending the HIV epidemic,” said CEO Daniel O’Day.

BIO Notebook: Policy Problems, ACIP’s Future, BI Is Popular, Makary On FDA-Industry Ties

Highlights from Day Two of the BIO International Convention include BIO officials raising concerns about Trump Administration policies, the future of ACIP, an interview with BI's head of global business development, and FDA Commissioner Martin Makary's view of the FDA-industry relationship.

FDA Takes World Tour In Recent OTC Warnings

FDA Center for Drug Evaluation and Research Office of Manufacturing Quality, Office of Compliance and Office of Unapproved Drugs & Labeling Compliance recently advise Indian, Canadian and US firms about GMP problems.

Wellness Firms Targeting GLP-1 Patients’ Dietary Needs Keep Option To Provide Access To Oral Rx

Health and wellness brands and retail chains providing access to prescriptions for compounded GLP-1 drugs, most also offering supplements curated to help meet dietary needs of GLP-1 patients, are offering formulations in oral form as well as injection.