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Food and Drug Administration (FDA) › Notification Requirements

Epstein Becker & Green

FDA Releases Draft Guidance on New Dietary Ingredient Notification Procedures, Timelines

Epstein Becker & Green on

On March 5, 2024, the Food and Drug Administration (FDA) issued its “Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry” (“Final Guidance”). The purpose of the Final...more

Arnall Golden Gregory LLP

Tell Me, I’ve Got to Know: FDA Issues Draft Guidance on 506J Notifications for Medical Devices

Arnall Golden Gregory LLP on

Bob Dylan sang, “Tell Me, I’ve Got to Know.” In January 2022, the Food and Drug Administration said the same to the medical device industry when it issued a draft guidance, “Notifying the FDA of a Permanent Discontinuance or...more

Goodwin

Field Alert Reporting: Supplier Contracting Implications for Drug Developers

Goodwin on

For emerging companies establishing their first supply chains, ensuring notification requirements in supply agreements for when commercial-stage manufacturing issues arise may not be top of mind. However, it is important for...more

Hogan Lovells

HHS proposal to exempt medical devices from 510(k) process halted

Hogan Lovells on

On January 15, the U.S. Department of Health and Human Services (HHS) published a notice and request for information (RFI) proposing to exempt 91 medical devices – for which the normal regulatory process was temporarily...more

American Conference Institute (ACI)

[Webinar] What New Dietary Ingredient Master Files Mean for Innovation & Compliance - May 27th, 1:00 pm - 2:00 pm EST

American Conference Institute (ACI) on

FDA first raised the concept of Master Files for dietary supplements in its 2016 revised NDI Guidance. The agency views master files as a tool to promote better compliance with NDI notification requirements. Ingredient...more

Faegre Drinker Biddle & Reath LLP

Christmas in July for Wellness Apps and Devices

Faegre Drinker Biddle & Reath LLP on

The Food and Drug Administration (FDA) released a final guidance on July 29, 2016, saying that it does not plan to require pre-market review for low-risk "general wellness products," such as wearable fitness monitors,...more

Mintz - Health Care Viewpoints

Emerging State Biosimilar Laws – Reference Chart and Five Issues to Watch

Mintz - Health Care Viewpoints on

As we’ve previously discussed, states have begun to actively regulate the substitution of interchangeable biosimilars before any FDA-approved biosimilar has even hit the market. State biosimilar legislation passed to date...more

Knobbe Martens

FDA Plan to Exempt Medical Devices

Knobbe Martens on

The US Food and Drug Administration (“FDA”) recently released updated recommendations to exempt certain unclassified, Class I, and Class II medical devices from premarket notification requirements. The devices include...more

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