Top Industry News
- MHRA Guidance published on the new international regulatory recognition routes for medicines approvals
- TGA increases regulatory oversight of sports supplements in medicinal dosage forms
- FDA Guidance on Electronic Submission Template for Medical Device 510(k) Submissions
- New Food Additives and Concentration Limits Proposed in Updated MERCOSUR GMC Resolutions, Paraguay Seeks Adoption with Comment Deadline on October 28, 2023
- MHRA outlines impact of revised pharmacovigilance compliance model on inspection findings
- The Food Safety Commission of Japan has recently updated its database for chemical toxicity assessments
- FDA Institutional Review Board (IRB) Review of Individual Patient Expanded Access Submissions for Investigational Drugs and Biological Products
- FDA Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission
- FDA Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions
- DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs Guidance for Industry
- Updates to Turkish Food Codex Regulations (Communiqué No: 2023/28) Enhance Protein, Essential Amino Acid, and Nutritional Standards for Baby Formulas and Follow-up Formulas
- Announcement by the State Food and Drug Administration: Incorporation of 21 Revised Aspects, Including pH Determination Techniques for Water-in-Oil Cosmetics, into the Safety and Technical Specifications for Cosmetics (2015 Edition) (No. 2023 of 41)
Mergers & Acquisitions
- Coherus Completes Surface Oncology Acquisition
- Life science: Cerba HealthCare to acquire canadian contract research laboratory CIRION BioPharma Research to expand bioanalytical capabilities and shorten time-to-deploy complex clinical trials
- Leading Independent Proxy Advisory Firm ISS Recommends Paratek Pharmaceuticals Stockholders Vote FOR the Acquisition by Gurnet Point Capital and Novo Holdings