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DMF

Completeness Assessments for Type II API DMFs Under GDUFA

FDA Guidance for the Industry Completeness Assessments for Type II API DMFs Under GDUFA By Global Compliance Seminar (LinkedIn; Twitter) This guidance is intended for holders of Type (more…)

Staff Editor June 17, 2016 FDA Guidance Read more

FDA Drug Master File Guidelines

FDA Drug Master File Guidance TABLE OF CONTENTS I. INTRODUCTION II. DEFINITIONS III. TYPES OF DRUG MASTER FILES IV. SUBMISSIONS TO DRUG MASTER FILES A. (more…)

Staff Editor April 10, 2014August 9, 2015 FDA Guidance Read more

Recent Posts

  • 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
  • FDCA 522 Postmarket Surveillance
  • Comparability Protocols for Human Drugs and Biologics CMC
  • 510K Submission and Review of Sterility Information
  • FDA Guidance for Digital Pathology Whole Slide Imaging Devices
  • Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices
  • Safety Considerations for Product Design to Minimize Medication Errors
  • CGMP Final Rule for Human and Veterinary Drugs
  • FDA Guidance for Sponsors CIs IRBs and Form FDA 1572
  • FDA Evaluation and Labeling of Abuse-Deterrent Opioids
  • FDA Recommendations for Generic Solid Oral Opioids
  • Medical Device Quality System Data for Surveillance Inspections 2015
  • Implementation of the Deemed to be a License Provision of BPCIA
  • Clinical Considerations for IDEs for Neurological Devices
  • Distributing Scientific and Medical Publications on Risk Information
  • Refusing, Delaying, Denying and Limiting FDA Inspection

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  • 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

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  • FDA underscores that consumers should not use drugs, dietary supplements and devices recalled from Basic Reset and Biogenyx following consent decree for federal violations
  • Statement from Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research, on impurities found in diabetes drugs outside the U.S.
  • FDA sends warning to companies for offering unapproved umbilical cord blood products that may put patients at risk
  • FDA approves first generics of Gilenya
  • FDA authorizes marketing of diagnostic test that uses novel technology to detect MRSA bacteria
  • FDA launches app for health care professionals to report novel uses of existing medicines for patients with difficult-to-treat infectious diseases
  • FDA approves novel treatment to target abnormality in sickle cell disease
  • FDA orders Puerto Rico fertility clinic to cease manufacturing immediately for significant violations that pose a danger to health
  • Statement on efforts to help make development of biosimilar and interchangeable insulin products more efficient
  • California-based food manufacturer agrees to stop production after repeated food safety violations
  • Statement on new steps to advance innovation in medical device sterilization with ethylene oxide
  • Statement by FDA Commissioner Scott Gottlieb, M.D., and Biologics Center Director Peter Marks, M.D., Ph.D. on FDA’s continued efforts to stop stem cell clinics and manufacturers from marketing unapproved products that put patients at risk
  • FDA approves system for the delivery of ear tubes under local anesthesia to treat ear infection
  • FDA warns 15 companies for illegally selling various products containing cannabidiol as agency details safety concerns
  • FDA approves new treatment for adults with partial-onset seizures

Recent Posts

  • 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
  • FDCA 522 Postmarket Surveillance
  • Comparability Protocols for Human Drugs and Biologics CMC
  • 510K Submission and Review of Sterility Information
  • FDA Guidance for Digital Pathology Whole Slide Imaging Devices
  • Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices
  • Safety Considerations for Product Design to Minimize Medication Errors
  • CGMP Final Rule for Human and Veterinary Drugs
  • FDA Guidance for Sponsors CIs IRBs and Form FDA 1572
  • FDA Evaluation and Labeling of Abuse-Deterrent Opioids
  • FDA Recommendations for Generic Solid Oral Opioids
  • Medical Device Quality System Data for Surveillance Inspections 2015
  • Implementation of the Deemed to be a License Provision of BPCIA
  • Clinical Considerations for IDEs for Neurological Devices
  • Distributing Scientific and Medical Publications on Risk Information
  • Refusing, Delaying, Denying and Limiting FDA Inspection

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