Top Industry News
- May deadline for FDA's eCTD transition approaches
- Standard operating procedure for management of periodic safety update reports (PSURs) for centrally authorised veterinary medicinal products: Annex I – contact details of national competent authorities (NCAs) for PSUR submission (Updated)
- FDA -New & Revised draft guidances CDER is planning to publish during calendar year 2017
- FDA - Requirements for transactions with first responders under Section 582 of the Federal Food, Drug, and Cosmetic Act — Compliance Policy Guidance for Industry
- MHRA - Medicines: Apply for a variation to your marketing authorisation
- Good Review Management Principles and Practices for effective IND development and review
- EMA - Over 1,000 studies now recorded in EU register of post-authorisation studies
- TGA - Changes to accessing unapproved therapeutic goods through the Authorised Prescriber (AP) and Special Access Schemes (SAS)
- EMA weighs new guideline on quality requirements for Combination Products
- TGA - Reforms to the regulatory framework for complementary medicines
- China works to reduce massive backlog of clinical trial and marketing applications
- ICH guideline E17 on general principles for planning and design of multi-regional clinical trials (Updated)
Mergers & Acquisitions
- Takeda completes acquisition of ARIAD Pharmaceuticals, Inc
- Catalent completes accucaps acquisition to expand softgel development and manufacturing capabilities and capacity
- Kalytera completes acquisition of Talent Biotechs
- Hill-Rom completes acquisition of Mortara Instrument
- Quotient Clinical announces second US acquisition: QS Pharma