Latest Posts › Federal Food Drug and Cosmetic Act (FFDCA)

Share:

FDA’s Attempt to Regulate Lab-Developed Tests Struck Down in Federal Court

On March 31, a judge in the Eastern District of Texas vacated the US Food and Drug Administration’s (FDA) rule that sought to regulate laboratory-developed tests (LDTs) as medical devices under the Federal Food, Drug, and...more

FDA Issues New Cosmetics Proposed Rule: Let’s Talk About Talc

Two years after the enactment of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), the US Food and Drug Administration (FDA) has published the long-awaited proposed rule on talc-containing cosmetics....more

Three Overhauls to Accelerated Drug Approval You Need to Know About: Novel Endpoints, Confirmatory Trials, and Expedited...

Earlier this month, the US Food and Drug Administration (FDA) issued new draft guidance regarding their accelerated approval pathway for new drugs and biologics, an expedited program designed to help address unmet medical...more

Deadline to Register Cosmetic Facilities and List Cosmetic Products Fast Approaches

Companies subject to the requirements of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) should take note that the deadline to register cosmetic facilities and list cosmetic products is fast approaching on July...more

FDA Draft Guidance Provides Further Details on New Cosmetic Product Facility Registration and Product Listing Requirements

Earlier this week, the US Food and Drug Administration (FDA) issued draft Q&A guidance entitled “Registration and Listing of Cosmetic Product Facilities and Products,” which clarifies the agency’s expectations regarding the...more

Consolidated Appropriations Act, 2023 Contains Significant Provisions for Cosmetic Products

On December 20, 2022, the US Senate unveiled the long-awaited federal omnibus spending bill. The US House of Representatives passed—and President Biden signed—the bill three days later, which will keep the federal government...more

FDA Proposes to Revise “Intended Use” Regulations (Again) to Clarify that Knowledge Alone Is Not Sufficient to Establish Intent

Last week FDA published a proposed rule that would revise the agency’s “intended use” regulations to clarify that a manufacturer’s knowledge of off-label use of its drug or device is, by itself, not sufficient to establish a...more

TTAB: Hemp Oil Extracts Marketed as Dietary Supplements Are Ineligible for Trademark Registration

The United States Trademark Trial and Appeal Board (TTAB) recently affirmed a refusal to register a trademark for “hemp oil extracts” when used as an ingredient in dietary supplements, finding that the applicant could not...more

Legislation Introduced to Define the Term ‘Natural’ for Personal Care Products

If enacted, the law would amend the Federal Food, Drug, and Cosmetic Act (FDCA) to require cosmetic products labeled as “natural” to contain at least 70 percent natural substances, (excluding water and salt) and be made...more

9 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide