FDA Law Blog

MARCH 6, 2022

The gap between QSR requirements and ISO standards has created confusion for companies that focused compliance only on ISO certification. For example, the proposed regulation provides that, for compliance with the ISO section on “Identification,” a device must be labeled with a UDI. See, e.g. , FDA Warning Letter to San Up S.A.

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The Pharma Data

APRIL 27, 2022

In particular, Action Levels for Lead in Juice: Draft Guidance for Industry , provides draft action levels of 10 parts per billion (ppb) for lead in single-strength apple juice and of 20 ppb for lead in all other single-strength juice types, including juice blends that contain apple juice. Source link: [link].

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FDA Law Blog

JANUARY 1, 2024

The FDA compliance data, sorted by category, shows there were 159 Warning Letters issued to drug manufacturers or sponsors during 2023, with 161 issued in calendar year 2022. Patcos Cosmetics Pvt. Summaries of the most striking recently released Warning Letters are included below.

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Pharma in Brief

JANUARY 7, 2024

Section 804 Importation Programs On October 1, 2020, the FDA published a rule entitled Importation of Prescription Drugs (the US Importation Rule ) to implement Section 804 of the Food, Drug, and Cosmetic Act.

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FDA Law Blog

SEPTEMBER 17, 2024

OPDP alleges in this latest letter that the DTC TV ad made false or misleading representations and suggestions about the efficacy of UBRELVY, which is considered misbranding of the product under the Federal Food, Drug, and Cosmetic Act. Another point of interest is contained in footnote 6. Advantage, OPDP.

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FDA Law Blog

NOVEMBER 1, 2023

Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Lenz, Principal Medical Device Regulation Expert & Sophia R. Gaulkin & Jeffrey N.

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FDA Law Blog

FEBRUARY 21, 2024

Both ISO 13485 and ISO 9000 contain terms and definitions that are referenced within Part 820. FDA encourages parties to require compliance with such requirements through contractual agreements between manufacturers. Revised § 820.3 FDA further retained some definitions in the QSMR.

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FDA Law Blog

JUNE 12, 2023

The Federal Food, Drug, and Cosmetic Act (FDC Act) requires that all animal foods, like human foods, be safe to eat, produced under sanitary conditions, contain no harmful substances, and be truthfully labeled. By Riëtte van Laack — FDA regulates pet food similar to other animal foods.

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FDA Law Blog

FEBRUARY 29, 2024

From there, the PTO notes that a PTE “determination is made based on the representations contained in the PTE application,” and that “35 U.S.C. § Moreover, Lilly should explain how a PTE application for a withdrawn “revoked” biologics license application is in compliance with requirements of 37 C.F.R.

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FDA Law Blog

JANUARY 14, 2025

By Ritte van Laack A little over two years ago, the Modernization of Cosmetic Regulation Act (MoCRA) was (at long last) enacted. Excitement that after about a decade the FDC Act finally was amended giving cosmetics more legitimacy; anxiety because MoCRA seemed a substantial change for many involved in the business of cosmetics.

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FDA Law Blog

OCTOBER 14, 2024

FDA also regulates HCT/Ps, defined as “articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient,” including bone, ligament, skin, cornea, stem cells derived from blood, and reproductive tissue. California Stem Cell Treatment Center, Inc.,

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