As the December 29, 2023 deadline for certain aspects of the Modernization of Cosmetics Regulation Act (“MoCRA”) approaches, FDA has finalized its guidance document governing the registration of cosmetic manufacturing...more
Cosmetics Regulation -
Currently, cosmetics are regulated through the Federal Food, Drug, and Cosmetic Act (FDCA)– which has recently been revamped by the Modernization of Cosmetics Regulation Act (MoCRA)–and various...more
On November 8, 2023, FDA issued a Final Guidance entitled Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing (“FDA Guidance”) extending some upcoming deadlines set forth in the...more
California has become the first U.S. state to ban the use of four potentially harmful food and drink additives. On October 7, 2023, Governor Gavin Newsom signed into law California Assembly Bill 418, the California Food...more
On August 7, 2023, FDA issued a draft guidance document entitled Registration and Listing of Cosmetic Product Facilities and Products: Guidance for Industry (“The Draft Guidance”), providing FDA’s current thoughts on the...more
The Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”) contains several provisions that will go into effect on December 29, 2023. We have previously explained some of the main provisions of MoCRA in Amendments to...more
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is bringing sweeping changes to the cosmetics industry. One such change requires a “responsible person” to maintain and submit certain adverse event reports to...more
The recently enacted Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”) requires FDA to adopt regulations governing Good Manufacturing Practices (“GMPs”) for the manufacture of cosmetic products and ingredients. H.R....more
For several years, the U.S. Department of Agriculture (“USDA”) has been working to revise the dietary requirements for the National School Lunch Program (“NSLP”) and other federally funded school meal programs. On February 7,...more
On December 30th, 2022, President Biden signed into law the Food and Drug Omnibus Reform Act of 2022 (“FDORA”), which included an Act now signed into law entitled the Modernization of Cosmetic Regulations Act of 2022...more
For nearly forty years, the Food and Drug Administration (“FDA”) has required applicants seeking approval of “generic” or “branded generic” drugs under section 505(b)(2) of the Federal Food, Drug and Cosmetics Act (“FDCA”) to...more
On May 26, Senators Murray and Burr introduced S. 4348 (pg. 97). The primary focus of the bill was to pass reauthorizations of FDA’s critical user fee programs for drugs, medical devices and biologics, which are scheduled to...more
On October 2, 2020, the Federal Circuit issued a precedential opinion vacating a district court’s judgment as a matter of law and reinstating a jury verdict finding of induced infringement of a patented use that had been...more
FDA recently issued its new final guidance concerning the appropriate pathway for review of drug-device combination products, Principles of Premarket Pathways for Combination Products Guidance for Industry and FDA Staff. In...more
On October 2, 2020, the Federal Circuit issued a precedential opinion vacating a district court’s judgment as a matter of law and reinstating a jury verdict finding of induced infringement of a patented use that had been...more
On April 23, 2021, President Biden signed into law The Ensuring Innovation Act (S. 415), which amends the requirements for New Chemical Entity (NCE) and Orphan Drug (ODE) exclusivities under the Federal Food, Drug, and...more
On October 2, 2020, the Federal Circuit issued a precedential opinion vacating a district court’s judgment as a matter of law and reinstating a jury verdict finding of induced infringement of a patented use that had been...more
Section viii of the Hatch-Waxman Act, 21 U.S.C. § 355(j)(2)(A)(viii), allows a generic applicant to “carve out” indications and other use information from its labeling that are protected by patents listed in FDA’s Orange Book...more
The COVID-19 pandemic presents ongoing challenges to the pharmaceutical and biologics industries, where in-person inspection of facilities is often required for FDA approval of applications to market drug or biological...more
The FDA has taken action to accelerate the approval of Abbreviated New Drug Applications (“ANDAs”). With a goal of reducing the number of review cycles needed to reach approval, the FDA will save generic drug companies money...more
On October 6, 2016, nearly thirteen years after passage of the Medicare Modernization Act (MMA), FDA published a final rule in the Federal Register implementing amendments and revisions to title 21 of the Code of Federal...more