Antimicrobial Drugs Clinical Study Regulations Harmonization
The FDA, EMA and PMDA aim at bringing harmonization in regulations related to clinical studies conducted for novel antimicrobial drugs (antibacterial and antifungal) across USA, Europe and Japan.
FDA Guidance on Substantial Evidence of Effectiveness for Drugs and Biologics
OVERVIEW Companies developing novel drugs or biologic products for rare diseases or other life-threatening diseases can now plan clinical studies for Investigational New Drugs (INDs) to establish their drug or biologic candidate’s effectiveness and explore strategies reduce to their time to market with New draft guidance from FDA. GUIDANCE: ‘Providing Evidence of Effectiveness of Human Drug […]
Japan cutting prices of new drugs and off-patent drugs
The Ministry of Health, Labor and Welfare is proposing a considerable cut down in the pricing of both off-patent drugs and expensive innovative treatments, and also set up an annual review of the drug prices.