USFDA - Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs
USFDA draft guidance on : Cover Letter for Controlled Correspondences & ANDA Submissions
Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making
Draft Guidance on Assessing Registries to Support Regulatory Decision -USFDAYesterday, the USFDA
Draft Guidance for Device Software in Premarket Submissions - USFDA
Guideline for Registration of Drug-Medical Device & Med.Dev-Drug Combo Products - MALAYSIA -NPRA
Data Standards for Drug & Biological Product Submissions Containing Real-World Data - USFDA
ICH guideline Recommendation on Daily (PDE) Limits for Seven Mutagenic Impurities
USFDA’s Real-World Data: Assessing e-Health Records & Med Claims Data To Support Regulatory Decision
Draft MD Guidance on Performance Criteria for Safety and Performance Based Pathway - USFDA
Draft Guidance on PK-Based Criteria for Alternative Dosing Regimens for Treatment of Cancer - USFDA
Revised Draft Guidance on Bioequivalence Studies for Generic Drugs – US FDA
Guidance’s on GMP for Investigational Products & for R&D facilities -WHO
ICH Q13 Draft Guideline reaches Step 2 of the ICH process
Draft guidance for Transdermal Adhesion Systems– US FDA
Draft Guidance on Remanufacturing of Medical Devices- USA-FDA
Draft Guideline on Computerised Systems & Electronic Data in Clinical Trials -EMA
Core Patient-Reported Outcomes in Cancer Clinical Trials - USFDA
FDA’s New Draft Guidances on Device Postmarket Surveillance – For Comments