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Top Industry News
- FDA Guidance on Revising ANDA Labeling Following Revision of the RLD Labeling
- EMA to Support Establishment of the African Medicines Agency
- EMA Commission Proposes Measures to Improve the Availability of In Vitro Diagnostics
- The European Commission has Informed the World Trade Organization (WTO) Regarding the 22nd Adaptation to Technical Progress (ATP) for the EU Classification, Labelling, and Packaging Regulation. The Notification is Open for a 60-day Comment Period
- FDA Guidance on ANDA Submissions - Amendments and Requests for Final Approval to Tentatively Approved ANDAs
- FDA Draft Guidance on Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal Products
- ANVISA Notice That Will Select Innovative Medical Devices Has More Than 100 Proposals Registered
- EMA Confirms Measures to Minimise the Risk of Serious Side Effects With Medicines Containing Pseudoephedrine
- NPRA Malaysia - Notification of Updating the Duration of the Life Span of the COVID-19 Vaccine from 30 Months to 36 Months
- Cosmetics Europe has Released Guidelines to Assist Companies in Adhering to the EU Regulations Concerning Additional Fragrance Allergens
- EMA Major Update of the SME User Guide
- FDA Characterization of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic Devices
- MHRA - Letters and Medicine Recalls Sent to Healthcare Professionals in December 2023
- MHRA Introduces New Restrictions for Fluoroquinolone Antibiotics
- US FDA-3-Fucosyllactose (3-FL) as an Ingredient in Various Food Products for Infants and Young Children
- This African Standard for Cheeses in Brine covers raw materials, Compositional Requirements, Food Additives, Contaminants, Hygiene, Labelling, Packaging, and Methods of Sampling and Analysis
- IFRA has Introduced Joint Recommendations on Assessment of Regulatory Needs Reports (ARN)
- Update on EU news: Members of the European Parliament (MEPs) Approve a New Legislation Prohibiting Greenwashing and Deceptive Product Information
Mergers & Acquisitions
- Sanofi to Acquire Inhibrx, Inc.
- Bristol Myers Squibb Completes Acquisition of Mirati Therapeutics
- Oncodesign Services Acquires ZoBio
- NAYA Biosciences To Acquire Clinical Stage Gene Therapy Program for Leber's Hereditary Optic Neuropathy (LHON)
- Kyowa Kirin Successfully Completes Acquisition of Orchard Therapeutics