Top Industry News
- FDA Guidance on Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA
- Malaysia MDA Approach for New and Re-Registration of Medical Devices with Expired EC Certificates and Self-Declared Class B IVD
- FSANZ-Notification Circular - 298-24 | Food Standards Australia New Zealand
- ANVISA Launches Guidelines for Inspection of Clinical Analysis Services and Welcoming Therapeutic Communities
- Singapore HSA - Consultation on Guidance on Change Management Program (CMP) for SaMD
- FDA Guidance on Mammography Quality Standards Act and Regulation Amendments
- ANVISA Reissues Rule that Simplifies Rules for Registration and Import of Medicines and Vaccines
- MHRA Guidance on Good Laboratory Practice (GLP) for Safety Tests on Chemicals
- FDA: Electronic Submission Template for Medical Device De Novo Requests
- FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act
- FDA: Predetermined Change Control Plans for Medical Devices
- TGA - Post-Market Review of Spinal Cord Stimulator Devices
- Chile- Decree 47 Exempt Modifies Technical Standard No. 209, of 2020, Which Sets Maximum Limits of Pesticide Residues in Food, Approved by Resolution No. 892, of 2020, of the Minsal
- Health Canada- Proposed Maximum Residue Limit PMRL2024-04, Fluopyram
- Update on OPSS product safety alerts and reports of cosmetic products posing a risk to the health and safety of consumers
- CTPA - EC Working Group on Cosmetics 13/14 June 2024
- EU Safety Gate Alerts July 2024
- International Fragrance Association (IFRA) has published its new IL on new ingredients self-classified as Toxic for Reproduction (CMR) Category 2 to be added to the IFRA-IOFI Labelling Manual 2024
- EU Introduces New Regulation on Maximum Nickel Levels in Food, Effective July 2025—32 Food Categories Impacted