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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

RSS FDA Regulatory Consulting Services

  • 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

RSS GLOBAL COMPLIANCE SEMINAR

  • 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

RSS Food and Drug Administration–Press Releases

  • FDA and DHS increase coordination of responses to medical device cybersecurity threats under new partnership; a part of the two agencies’ broader effort to protect patient safety
  • Statement by FDA Commissioner Scott Gottlieb, M.D., on FDA’s new steps to modernize drug development, improve efficiency and promote innovation of targeted therapies
  • FDA advances investigation into whether more than 40 e-cigarette products are being illegally marketed and outside agency's compliance policy
  • FDA approves new DNA-based test to determine blood compatibility
  • La FDA aprueba el uso ampliado de Gardasil 9 para incluir a personas de 27 a 45 años de edad
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance the development of generic copies of complex drugs to improve patient access to medicines
  • FDA approves expanded use of Gardasil 9 to include individuals 27 through 45 years old
  • FDA allows marketing of first self-fitting hearing aid controlled by the user
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on new agency actions to further deter ‘gaming’ of the generic drug approval process by the use of citizen petitions
  • Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA’s efforts to strengthen the agency’s medical device cybersecurity program as part of its mission to protect patients
  • FDA approves a new antibacterial drug to treat a serious lung disease using a novel pathway to spur innovation
  • FDA approves first treatment for advanced form of the second most common skin cancer
  • FDA authorizes first next generation sequencing-based test to detect very low levels of remaining cancer cells in patients with acute lymphoblastic leukemia or multiple myeloma
  • Statement by FDA Commissioner Scott Gottlieb, M.D., on preparations for the upcoming flu season and vaccinations
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on modernizing standards of identity and the use of dairy names for plant-based substitutes

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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RSS Quest for Regulatory Compliance

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  • 2016 February MDRs for Essure
  • FDA Safety Alert for EOS Lip Balm Products
  • FDA Warned A Drug Manufacturer for Data Falsification
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  • US Supreme Court Justice Dies During Vacation in Texas
  • Pfizer Hit with False and Misleading Video for Precedex
  • US Enters Consent Decree Against Texas Drug Manufacturer

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