Top Industry News
- FDA Statement on Medical Device User Fee Agreement (MDUFA)
- ANDA Submissions – Refuse to Receive for Lack of Justification of Impurity Limits Guidance for Industry
- FDA-UDI Exceptions, Alternatives and Time Extensions
- MHRA Updates Guidance on Determining Whether an app is a Medical Device
- CDSCO has prepared a detailed checklist for all the requirements of GMP and GLP
- FDA proposes new rule to overhaul regulations for nonclinical studies
- Australian Public Assessment Reports for prescription medicines (AusPARs)