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Top Industry News
- ANVISA has a New Model for Technical Opinion for Registration of Biological Products
- China Makes Progress in Traditional Chinese Medicine (TCM) Development
- PMDA - Information on Clinical Trials conducted from a Humanitarian Perspective (Medicines, Devices/Regeneration) has been Updated.
- PMDA Survey Results Regarding The Safe Use of Pharmaceuticals, Medical Devices, Regenerative Medicine Products, etc.
- FDA Enforcement Policy for Certain Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions
- HSA Singapore’s HSA Queries on Device Evaluation Guidance Changes
- FDA Releases Latest Information Regarding Registration of Cosmetic Product Facilities and Listing of Cosmetic Products
- PMDA - "Generic Drug Quality Information No.17" has been published.
- FDA Approves Interchangeable Biosimilar for Multiple Inflammatory Diseases
- Swissmedic Revision of the MepV and the IvDV
- PMDA Regarding Operational Changes to Consultation Reception Operations (From May 8, 2023)
- PMDA Medical Safety Information
- FDA - Submitting Patient-Reported Outcome Data in Cancer Clinical Trials
- MHRA to Launch The AI-Airlock, a New Regulatory Sandbox for AI Developers
- MHRA Medical Devices Given Exceptional Use Authorisations During the COVID-19 Pandemic
- FDA Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices
- ANVISA Anvisa Hosts the MDSAP Annual Forum in Brasília
- Addition of Cosmetic Ingredients to the Mandatory Classification List in GB
- The FDA is Suggesting the Prohibition of a Food Additive While also Continuing Evaluations of Other Chemicals
- FDA - Submitting Clinical Trial Datasets and Documentation for Clinical Outcome Assessments Using Item Response Theory
- ANVISA Approves Drug to Prevent Respiratory Syncytial Virus (RSV)
- Food Standards Australia New Zealand (FSANZ) is inviting feedback on a request to authorize the commercialization and consumption of food produced from a recently developed genetically modified (GM) soybean.
- ANVISA Enables the First Company to Import Germ Cells and Embryos in Brazil
- PMDA - A Simple Consultation Schedule for December has been Posted (Medicinal Products, etc.)
Mergers & Acquisitions
- Korro Bio and Frequency Therapeutics Announce Closing of Merger and Private Placement of $117 Million
- Aileron Therapeutics Announces Acquisition of Lung Therapeutics
- Resolian Acquires China-Based Bioanalytical CRO Denali Medpharma
- Noramco Announces the Acquisition of the Cambrex Drug Product Business Unit
- Starton Therapeutics Announces Termination of Business Combination Agreement with Healthwell Acquisition Corp
- Ligand Acquires Royalty on Sanofi’s TZIELD® for $20 Million