US FDA: Patient-Focused Drug Development: Incorporating…
US FDA proposed draft guidance titled “Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for…
Read more
Sweden Informed ECHA of its Intention to Classify Carvo…
Sweden submitted to ECHA (European Chemical Agency) on 27 March 2023 its intention of harmonized classification and labelling (CLH) of Carvo…
Read more
US FDA Proposed Draft Guidance on Premarket Submissions…
The U.S. Food and Drug Administration (FDA) proposed a draft guidance document that provides recommendations to applicants, and submitters o…
Read more
EU Published Amendments Regarding Reference Points for …
The EU has published amendments regarding the Commission Regulation (EU) 2023/411 on 23 February 2023 amending Regulation (EU) 2019/1871 in …
Read more
Indonesia Ministry of Health Published News Regarding T…
Indonesia Ministry of Health published news regarding The Draft Health Law is a Solution for the Independence of Pharmaceuticals and Medical…
Read more
Japan Amended the Food Labelling Standards to Add Walnu…
On 9 March 2023, the Consumer Affairs Agency (CAA) announced that they have published amendments to the Food Labelling Standards (Cabinet Or…
Read more
Mexico Published Amendments to the Guidelines for Food …
The Federal Commission for Protection against Health Risks (COFEPRIS) published amendments on 13 March 2023, to draft guidelines for adverti…
Read more
New Zealand | Proposal to Amend the Cosmetics Products …
On 14 March 2023, New Zealand notified the WTO of a proposal to amend its Cosmetic Products Group Standard 2020. In particular, the text pro…
Read more
FDA Issues Final Guidances to Assist with Transition Pl…
The final transition guidances provide recommendations and clarity for medical device manufacturers that may or may not want to continue to …
Read more
EU Published Amendments on the Authorisation to Place P…
EU published amendments on the authorization to place products containing, consisting of, or produced from genetically modified soybean A554…
Read more