Richard Starr on Food and Drug Administration (FDA)

FDA Issues a New Draft Guidance on New Dietary Ingredient Notification Master Files for Dietary Supplements

As promised last month, we are happy to announce that on April 3, FDA issued the New Dietary Ingredient Notification Master Files for Dietary Supplements draft guidance. In a related constituent update, FDA explained that the...more

4/8/2024 / Comment Period , Dietary Supplements , Draft Guidance , Food and Drug Administration (FDA)

FDA Finalizes Section V of the 2016 Revised Draft NDI Guidance

On March 4, FDA announced the availability of a final guidance, Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes – Guidance for Industry. The guidance finalizes Section V: NDI Notification...more

3/11/2024 / Dietary Supplements , Filing Requirements , Final Guidance , Food and Drug Administration (FDA) , Manufacturers

Medical Device Update: FDA Publishes Three New Guidance Documents for the 510(k) Premarket Notification Program

The latest efforts by the U.S. Food and Drug Administration (FDA) to modernize regulation of the 510(k) program come in the form of a trio of new draft guidance documents regarding its Premarket Notification program for...more

10/9/2023 / Clinical Evaluations , Comment Period , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , New Guidance , Premarket Approval Applications

Prepare Now for the New FDA Requirements for Cosmetics Companies

Thanks to the Food and Drug Omnibus Reform Act (FDORA), cosmetic companies will soon be subject to new requirements for registration, product listing, disclosure of ingredients, adverse event reporting, safety substantiation,...more

7/21/2023 / Adverse Events , Best Practices , Cosmetics , Disclosure Requirements , Federal Food Drug and Cosmetic Act (FFDCA) , Filing Deadlines , Food and Drug Administration (FDA) , Interstate Commerce , Manufacturers , Manufacturing Facilities , New Legislation , Personal Care Products , Product Labels , Recordkeeping Requirements , Registration Requirement

DOD-FDA Enhanced Engagement to Accelerate the Development of Medical Products for Our Military Personnel

Since its enactment in 2017, Public Law No. 115-92 has significantly boosted the availability of medical products that protect and treat military personnel. Designed to overcome the unique challenges posed by military medical...more

4/24/2023 / Department of Defense (DOD) , Emergency Use Authorization (EUA) , Expedited FDA Approval , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Medical Devices , Military End Use , Pharmaceutical Industry

FDA Medical Device Updates to Emergency Use Authorizations and Enforcement Discretion Issued During the COVID-19 Public Health...

On March 24, 2023, the Food and Drug Administration (FDA) finalized two transition plan guidance documents for medical devices that either 1) were issued Emergency Use Authorizations (EUAs), or 2) received enforcement...more

3/28/2023 / Clinical Laboratories , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Diagnostic Tests , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , New Guidance , Public Health Emergency

FDA Infant Formula Updates: New Labeling Guidance, Call for Enhanced Safety Measures, and Draft Protein Efficiency Ratio Testing

Infant formula manufacturers should be aware of several recent actions taken by the Food and Drug Administration (FDA). In total, these actions reflect FDA's dedication of resources to the infant formula industry....more

3/24/2023 / Baby Products , Draft Guidance , Food and Drug Administration (FDA) , Labeling , New Guidance

FTC Announces Health Products Compliance Guidance

On December 20th, 2022, the Federal Trade Commission published new guidance regarding claims about the benefits and safety of health-related products: Health Products Compliance Guidance. This guidance replaces the...more

12/22/2022 / Advertising , Compliance , Dietary Supplements , Disclosure Requirements , Federal Trade Commission (FTC) , Food and Drug Administration (FDA) , Health Claims , New Guidance , Prescription Drugs

Richard Starr

Venable LLP

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