Top Industry News
- Health Canada- Validation Rules for Regulatory Transactions Provided to Health Canada in the Electronic Common Technical Document (eCTD) Format
- SFDA- Guideline for Submitting a Claim Evaluation Request of Health and Nutrition Claims
- EUROPE: MDCG Guidance on Classification of In Vitro Diagnostic Medical Devices (IVD)
- Health Canada- Validation Rules for Regulatory Transactions Provided to Health Canada in the “non-eCTD electronic-only” Format
- SINGAPORE: Next Introduction UDI System for Medical Devices
- Health Canada- Validation Rules for Transactions Containing the Regulatory Enrolment Process (REP) Company XML File
- MHRA- Guidance on Submitting Clinical Trial Safety Reports from 1 January 2021
- TGA- Progress Update: Improving Post-Market Monitoring and Surveillance of Medical Devices
- MHRA- Guidance on MAH and QPPV Location from 1 January 2021
- HPRA- Guide for Distributors of Medical Devices
Mergers & Acquisitions
- Lilly Announces Agreement to Acquire Prevail Therapeutics
- Leading BioSciences and Seneca Biopharma Announce Merger to form Palisade Bio
- Philips to Acquire BioTelemetry
- Syneos Health Completes Acquisition of Synteract
- Cadent Therapeutics Enters Agreement to be Acquired by Novartis
- Integra LifeSciences Announces Definitive Agreement To Acquire ACell, Inc.
- Spinal Elements® Announces the Acquisition of Benvenue Medical Assets
- EmendoBio Gene Editing Company Acquired by AnGes, Inc.
- Anchiano Therapeutics and Chemomab Announce Entry Into Definitive Merger Agreement
- Reviva Pharmaceuticals, Inc. and Tenzing Acquisition Corp. Complete their Business Combination and Trade as Reviva Pharmaceuticals Holdings, Inc.