Top Industry News
- Three new FDA draft guidance documents for drug compounders
- Deadlines for submission of applications for orphan medicinal product designation to the EMA
- European Union (EU) - Clinical Trial Regulation
- Cooperation between regulators and HTA bodies creates synergies
- FDA offers specific guidance on Bioequivalence Trials for next generation of 38 generic drugs
- Promoting high-quality clinical research to develop more and better medicines for children
- Guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials
- FDA offers Data Integrity and Compliance with CGMP guidance for industry
- Generic drug approvals hit new record in 2015, FDA report shows