Advarra

JULY 26, 2022

Cannabis plants and derivatives containing no more than 0.3% Importantly, the 2018 Farm Bill preserved FDA authority to regulate products with cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic (FD&C) Act and Section 351 of the Public Health Service Act.

Regulation 97

Regulation Research Production Cosmetics 97

Camargo

NOVEMBER 15, 2021

The 21 st Century Cures Act generated a good deal of excitement and interest when it added a section called “ Utilizing Real World Evidence ” to the Food, Drug, and Cosmetic Act (Section 505F). The guidance also contains some useful information, despite the limitations described above. Manager, Regulatory Compliance.

Development 187

Development Manufacturing Production Packaging 187

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contained in the PTE application,” and that “35 U.S.C. § Moreover, Lilly should explain how a PTE application for a withdrawn “revoked” biologics license application is in compliance with requirements of 37 C.F.R.

Production 59

Production Drugs FDA Approval Compliance 59

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.

Regulation 52

Regulation Compliance Manufacturing Packaging 52

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.

Regulation 59

Regulation Manufacturing Packaging Packaging 59

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.

Regulation 45

Regulation Production Cosmetics Sales 45

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In particular, Action Levels for Lead in Juice: Draft Guidance for Industry , provides draft action levels of 10 parts per billion (ppb) for lead in single-strength apple juice and of 20 ppb for lead in all other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

Cosmetics 52

Cosmetics Production Containment Contamination 52

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.

Regulation 81

Regulation In-Vitro Manufacturing Licensing 81