Tag: FDA Updates

Pharma/Biotech – USA, Europe, Asia and ROW Regulatory News – Feb. 2024

March 7, 2024
Biopharma

USA FDA Modernizes Informed Consent Guidance, Aligning With Common Rule Changes The FDA has published new draft guidance on informed consent that lines up with revisions to the Common Rule made...

Asia Biotech News, Asia Regulations, Biotech News, DSCSA Compliance, EU Regulatory, FDA Updates, Global Healthcare, Pharma Regulations, Singapore Healthcare, Swiss Medic

Consumer Health-USA/Europe/Asia/ROW Regulatory News-Nov. 2023

December 7, 2023
Consumer Health

USA Structured Product Labeling (SPL) Implementation Guide with Validation Procedures for Cosmetic Product Facility Registrations and Product Listings The U.S. Food and Drug Administration published...

Consumer Health, cosmetics, FDA Updates, Healthcare Industry, Regulatory Changes, Regulatory News

Consumer Health-USA/Europe/Asia/ROW Regulatory News – Oct. 2023

October 26, 2023
Consumer Health

USA Canada Three New Food Enzymes Granted Approvals On October 11, 2023, Health Canada unveiled NOM/ADM-0209 with immediate effect, modifying the List of Permitted Food Enzymes to enable the...

Consumer Health, cosmetics, FDA Updates, Healthcare Industry, Regulatory Changes, Regulatory News

Consumer Health-USA and Asia Regulatory News-Sept 2023

September 26, 2023
Consumer Health

USA FDA Issues Draft Guidance on Registration and Listing of Cosmetic Product Facilities and Products FDA is seeking comments on its newly developed draft electronic submission portal (Cosmetics...

Consumer Health, cosmetics, FDA Updates, Healthcare Industry, Regulatory Changes, Regulatory News

The Future of FDA Cosmetics Regulations: What to Expect in the Coming Years

June 5, 2023
Cosmetics

The FD&C Act defines cosmetics by their intended use, as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for cleansing,...

Cosmetic Compliance, Cosmetics Industry, FDA Cosmetics Regulations, FDA Updates

Medical Devices – USA/Europe Regulatory Updates round up – Sep 2021

October 6, 2021
Medical Device

EUROPE 1. Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred...

Europe, Europe FDA, Europe Medical Devices, Europe Regulatory Updates, FDA Updates, Medical quality, medicaldevice, Regulatory Updates, USA, Usa Medical Devices, USA Regulatory Updates