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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

  • Statement from FDA Commissioner Scott Gottlieb, M.D. and FDA Deputy Commissioner Anna Abram on emerging food innovation, “cultured” food products
  • FDA approves first generic versions of Suboxone sublingual film, which may increase access to treatment for opioid dependence
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s efforts to better equip consumers with nutritional information about dietary fiber in their food
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on new agency efforts to advance the patient voice in medical product development and FDA regulatory decision-making
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s efforts to foster discovery and development of new tools to fight antimicrobial-resistant infections
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance medical product communications to support drug competition and value-based health care
  • Federal judge enters consent decree against Delta Pharma
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on 2017 National Youth Tobacco Survey results and ongoing FDA efforts to protect youth from the dangers of nicotine and tobacco products
  • FDA seeks permanent injunction against company selling unapproved hand sanitizers that claim to prevent infections from numerous pathogens
  • FDA Deputy Commissioner for Policy, Planning, Legislation, and Analysis Anna Abram, remarks prepared for testimony before a subcommittee of the U.S. House Committee on Energy and Commerce on the Pandemic and All-Hazards Preparedness Act
  • FDA and USDA announce key step to advance collaborative efforts to streamline produce safety requirements for farmers
  • FDA takes action against 53 websites marketing unapproved opioids as part of a comprehensive effort to target illegal online sales
  • FDA warns companies to stop selling dangerous and illegal pure and highly concentrated caffeine products
  • FDA approves first biosimilar to Neulasta to help reduce the risk of infection during cancer treatment
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on proposed modernization of FDA’s drug review office

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

  • St Jude Files Suit- St. Jude v. Muddy Waters Consulting LLC and Others
  • Former FDA Commissioner and Her Husband Sued Over Drug Levaquin
  • BSC Is Recalling Fetch 2 Aspiration Catheter Due to Shaft Breakage
  • 2016 February MDRs for Essure
  • FDA Safety Alert for EOS Lip Balm Products
  • FDA Warned A Drug Manufacturer for Data Falsification
  • FDA Video on the Laser Pointers for Risk of Eye and Skin Injuries
  • 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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