- Feb 6, 2022
- 1 min
USFDA - Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs
- Dec 11, 2021
- 1 min
USFDA draft guidance on : Cover Letter for Controlled Correspondences & ANDA Submissions
- Dec 11, 2021
- 2 min
Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making
- Nov 30, 2021
- 1 min
Draft Guidance on Assessing Registries to Support Regulatory Decision -USFDAYesterday, the USFDA
- Nov 7, 2021
- 1 min
Draft Guidance for Device Software in Premarket Submissions - USFDA
- Nov 7, 2021
- 1 min
Guideline for Registration of Drug-Medical Device & Med.Dev-Drug Combo Products - MALAYSIA -NPRA
- Nov 7, 2021
- 1 min
Data Standards for Drug & Biological Product Submissions Containing Real-World Data - USFDA
- Oct 13, 2021
- 1 min
ICH guideline Recommendation on Daily (PDE) Limits for Seven Mutagenic Impurities
- Sep 29, 2021
- 2 min
USFDA’s Real-World Data: Assessing e-Health Records & Med Claims Data To Support Regulatory Decision
- Aug 30, 2021
- 1 min
Draft MD Guidance on Performance Criteria for Safety and Performance Based Pathway - USFDA
- Aug 30, 2021
- 1 min
Draft Guidance on PK-Based Criteria for Alternative Dosing Regimens for Treatment of Cancer - USFDA
- Aug 21, 2021
- 1 min
Revised Draft Guidance on Bioequivalence Studies for Generic Drugs – US FDA
- Aug 8, 2021
- 1 min
Guidance’s on GMP for Investigational Products & for R&D facilities -WHO
- Jul 28, 2021
- 1 min
ICH Q13 Draft Guideline reaches Step 2 of the ICH process
- Jul 5, 2021
- 1 min
Draft guidance for Transdermal Adhesion Systems– US FDA
- Jun 26, 2021
- 1 min
Draft Guidance on Remanufacturing of Medical Devices- USA-FDA
- Jun 26, 2021
- 1 min
Draft Guideline on Computerised Systems & Electronic Data in Clinical Trials -EMA
- Jun 19, 2021
- 1 min
Core Patient-Reported Outcomes in Cancer Clinical Trials - USFDA
- Jun 11, 2021
- 1 min
FDA’s New Draft Guidances on Device Postmarket Surveillance – For Comments