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Food and Drug Administration (FDA) › Registration

ArentFox Schiff

FDA Delays Enforcement of Cosmetic Facility Registration and Product Listing Requirements

ArentFox Schiff on

On November 8, the US Food and Drug Administration (FDA) announced its intent to delay enforcement of the requirements for cosmetic product facility registration and cosmetic product listing. On November 8, the US Food and...more

Davis Wright Tremaine LLP

FDA Releases Draft Guidance for Cosmetic Facility Registration and Product Listing

Davis Wright Tremaine LLP on

Over half a year after Congress passed a law modernizing the regulation of cosmetics in the U.S. (the Modernization of Cosmetics Regulation Act or "MoCRA"), the U.S. Food and Drug Administration ("FDA") has released draft...more

ArentFox Schiff

FDA Draft Guidance Provides Further Details on New Cosmetic Product Facility Registration and Product Listing Requirements

ArentFox Schiff on

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

Mintz - Health Care Viewpoints

FDA Publishes Draft Guidance on Cosmetic Product Facility Registration and Cosmetic Product Listing

Mintz - Health Care Viewpoints on

On August 7, 2023, the Food and Drug Administration (FDA) published Draft Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products (the Draft Guidance), which provides much-needed...more

Mintz - Consumer Product Safety Viewpoints

Coming Soon to a Lawbook Near You – New Cosmetic Requirements

Mintz - Consumer Product Safety Viewpoints on

Back in April 2015, Senators Dianne Feinstein (D-CA) and Susan Collins (R-ME) introduced the Personal Care Products Safety Act (S.1014). More recently, on September 22, 2016, the Senate Health, Education, Labor, and Pensions...more

Epstein Becker & Green

NIH Issues Proposed Rule Expanding Clinical Trial Registration and Reporting Obligations

Epstein Becker & Green on

On November 21, 2014, the National Institutes of Health (“NIH”) published a notice of proposed rulemaking regarding requirements for clinical trial registration and the reporting of results (“Notice” or “Proposed Rule”)....more

BakerHostetler

New Guidance for 503B Outsourcing Facilities

BakerHostetler on

Three guidance documents recently issued by the Food and Drug Administration (FDA) provide greater clarity for certain entities that compound sterile drugs. The new guidance addresses registration requirements, fees and drug...more

Akin Gump Strauss Hauer & Feld LLP

FDA Issues Three Guidance Documents for Outsourcing Facilities

Akin Gump Strauss Hauer & Feld LLP on

FDA has announced the availability of two Final Guidance documents and one revised Draft Guidance related to Section 503B outsourcing facilities. FDA published the three guidance documents Friday afternoon. The Final...more

Polsinelli

Key Points: Compounding Quality Act

Polsinelli on

The Compounding Quality Act (CQA) amends the U.S. Food, Drug & Cosmetic Act (Act) to create a new, voluntary category of compounders called "outsourcing facilities" (OF). Compounded drugs are those mixed by a pharmacist that...more

K&L Gates LLP

Congress Passes New Drug Compounding Law Increasing Federal Oversight Over Compounding Pharmacies

K&L Gates LLP on

In the fall of 2012, a meningitis outbreak sickened more than 750 people, killing 64 people and leaving many others with pain and nerve damage. The meningitis was traced back to tainted injectable steroids manufactured at a...more

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