Biologics License Application
FDA PMA and BLA for APLIGRAF and GINTUIT
Class III Medical Device and Biologics License Application (BLA) Class III Medical Device APLIGRAF: P950032 Expedited processing eras authorized on May 30 1995 based on the potential of Apligraf to provide a clinically important advance over existing alternatives in the treatment of chronic venous insufficiency ulcers. Intended Use/Indications Apligraf is indicated for use with standard therapeutic compression for the treatment of non infected partial and full
"Recombinant Esterase Inhibitor" Approved for the Treatment of Acute Attacks of Hereditary Angioedema
By Admin The United States Food and Drug Administration (FDA) approves Esterase Inhibitor (Recombinant)-RUCONEST FDA is issuing Department of Health and Human Services U.S. License No. 1857 to Pharming Group NV, (Leiden, the Netherlands, “firm”), under the provisions of section 351(a) of the Public Health Service Act controlling the manufacture and sale of biological products. The license authorizes the firm to
Recent Post
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
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
Login Status
You are not logged in. 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