FDA Guidance Information

Login Status

You are not logged in.
Forgot?  Register

Menu

  • Home
    • FEDERAL FOOD, DRUG, AND COSMETIC ACT
  • Drug Guidances
    • Drug Supply Chain Security Act (DSCSA)
    • FDA Final Rule for Orphan Drug Regulations
    • FDA Drug Supply Chain Security Act
    • FDA Guidance for Changes to an Approved NDA or ANDA
    • Changes to an Approved NDA or ANDA
    • Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products
    • 21 CFR 211 – Current GMP for Finished Pharmaceuticals
  • 510k Templates
  • Biologics Guidances
  • Biosimilars
  • cGMP for Dietary Supplements
  • Compliance Program Guidance Manual (CPGM)
  • Cosmetics
    • Cosmetic Good Manufacturing Practices
  • cGMP Requirements for Combination Products
  • Current Good Tissue Practice
  • Devices/IVDs
    • 21 PART 830 Unique Device Identification
    • Content of a Pre-Sub for a 510(k)
    • 21 CFR Part 820 Quality System Regulation
    • Applying Human Factors and Usability Engineering to Medical Device Design
    • Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
    • CPG Sec. 300.750 Class III Devices Subject to 515(b) Requirements
    • FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices
    • General Principles of Software Validation
    • 21 CFR Part 801 Labeling
  • GLP Comparison: FDA, EPA and OECD
  • GRAS Substances Database
  • FDA Regulations for Good Clinical Practices

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., on FDA’s new strategic framework to advance use of real-world evidence to support development of drugs and biologics
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new effort for developing and class labeling of in vitro companion diagnostics for classes of oncology therapeutic products
  • FDA takes new action to advance the development of reliable and beneficial genetic tests that can improve patient care
  • FDA authorizes first test to aid in detecting a type of herpes virus in newborns called cytomegalovirus
  • FDA warns company for selling e-liquids that resemble kid-friendly foods as part of the agency’s ongoing Youth Tobacco Prevention Plan
  • FDA approves first treatment for Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder
  • FDA approves treatment for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a certain genetic mutation
  • FDA approves first biosimilar for treatment of adult patients with non-Hodgkin’s lymphoma
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on how modern predicates can promote innovation and advance safety and effectiveness of medical devices that use 510(k) pathway
  • Statement by FDA Commissioner Scott Gottlieb, M.D., on risk of heavy metals, including nickel and lead, found in some kratom products
  • FDA warns consumers to avoid Rhino male enhancement products found at retailers because of undeclared and potentially dangerous drug ingredients
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on the current romaine lettuce <i>E. coli</i> O157:H7 outbreak investigation
  • FDA approves an oncology drug that targets a key genetic driver of cancer, rather than a specific type of tumor
  • Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on transformative new steps to modernize FDA’s 510(k) program to advance the review of the safety and effectiveness of medical devices
  • FDA approves new treatment for patients with acute myeloid leukemia

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

Login Status

You are not logged in.
Forgot?  Register

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

2013-04-16_510K_Templates

Copyright © 2017. FDA Guidance. All Rights Reserved.