About Us

FDA Regulatory Doctor

• Learn about Egg Safety
• Johnson and Johnson Baby Powder May Be Linked to Cancer
• Johnson and Johnson Baby Power May Be Linked to Cancer
• Understanding Essure Problems and Hysterectomy

FDA Guidance Information

• FDA Guidance on Expansion of the Abbreviated 510k Program
• Completeness Assessments for Type II API DMFs Under GDUFA

FDA Compliance Training

• Use of ISO 10993-1 Within a Risk Management Process
• FDA Final Rule for Use of Symbols in Labeling
• Registration, Evaluation, Authorisation and Restriction of Chemicals in EU
• Transition Date for EN ISO 13485 Amended to Be 31 March 2019
• FDA Electronic Medical Device Reporting and eMDR Files

Quest for Regulatory Compliance

• St Jude Files Suit- St. Jude v. Muddy Waters Consulting LLC and Others
• Former FDA Commissioner and Her Husband Sued Over Drug Levaquin

Recent Posts

• AHWP WG5 Clinical Evaluation
• UK MHRA and BSI Statements In Response to Brexit Referendum
• Global Adverse Event Databases
• Glyphosate in Food and Vaccines May Be Linked to Autism
• Movie for Chasing the Dragon – Opioid Addiction
• AHRQ Hospital Survey Report on Patient Safety Culture
• 21 CFR 820.70 Production and Process Controls
• FDA Proposes Ban on Electrical Stimulation Devices
• Improving Awareness of the Importance of Human Factors
• FDA Reclassifies Cardiovascular EPPG and PSA Devices into Class II

FDA Guidance

• FDA Guidance on Expansion of the Abbreviated 510k Program
• Completeness Assessments for Type II API DMFs Under GDUFA
• Use of ISO 10993-1 for Medical Device Risk Management Process
• FDA Data Integrity and Compliance with CGMP
• ANDA Submissions-Content and Format

FDA Press Releases