Top Industry News
- FDA Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities
- MHRA Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles
- The Office for Product Safety and Standards has Unveiled a CMR Management Process for Regulating Cosmetics in the UK
- FDA Expands Scope of Off-Label Guidance to Include Presentations from Reprints
- COFEPRIS Promotes New Regulatory Certainty Strategy for Medical Devices
- FDA Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles
- FDA Proposed Information Collection for Color Additive Certification in FDA for Regulated Products
- MHRA Software and Artificial Intelligence (AI) as a Medical Device
- PMDA Medical Safety Information
- MHRA The Innovative Devices Access Pathway (IDAP)
- ANVISA Published the Amendment to RDC 53/2015 and the IN on Qualified Impurities
- MHRA and International Partners Publish Five Guiding Principles for Machine Learning-enabled Medical Devices
- List of Authorised Orphan Medicinal Products Registered by the UK Licensing Authority
- HSA Consultation on GN-20 Guidance on Clinical Evaluation
- EMA Takes Further Steps to Address Critical Shortages of Medicines in the EU
- IMDRF Standard Operating Procedures
- ANVISA Creates a Monitoring Panel for the Regulatory Agenda
- European Environmental Bureau (EEB) Mercury-laden Cosmetics are Still Being Promoted as a 'Remedy' for Darker Skin Tones
- PMDA Information on Risks, etc. Under Evaluation Regarding Pharmaceuticals
- Ministry of Food and Drug Safety Transfers Technology to Vietnam to Strengthen ‘Food Safety Information System’ Management Capabilities
- ANVISA Defines Composition of Influenza Vaccines for 2024
- PMDA Information Regarding Case Reports with Suspected Defects (Regenerative Medicine Products)
- PMDA Institutional Review Board (IRB) Registration Information Updated
- FDA Topical Dermatologic Corticosteroids: In Vivo Bioequivalence
- PMDA Regarding the Reporting System Regarding the Vaccination Act
- MHRA Phase I Accreditation Scheme
Mergers & Acquisitions
- PharmaDrug Inc. Enters Definitive Agreement to Acquire SecureDose Synthetics
- Citius Pharmaceuticals Executes Definitive Agreement To Merge Wholly Owned Subsidiary With TenX Keane Acquisition To Form Publicly Listed Citius Oncology, Inc.
- Cybin Completes Acquisition of Small Pharma Inc. to Create International Clinical-stage Leader in Novel Psychedelic Therapeutics