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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 approves new treatment for a rare genetic disorder, Fabry disease
  • FDA approves new vaginal ring for one year of birth control
  • FDA approves first-of-its kind targeted RNA-based therapy to treat a rare disease
  • FDA allows marketing of first direct-to-consumer app for contraceptive use to prevent pregnancy
  • FDA alerts healthcare providers, women about risks associated with improper use of rupture of membranes tests
  • FDA approves treatment for two rare types of non-Hodgkin lymphoma
  • FDA approves first generic drug under new pathway aimed at enhancing market competition for sole source drugs
  • FDA takes new steps to encourage the development of novel medicines for the treatment of opioid use disorder
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps the agency is taking to support the development of novel nicotine replacement drug therapies to help smokers quit cigarettes
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s continued, careful oversight of the REMS associated with transmucosal immediate-release fentanyl products
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new efforts to advance antimicrobial stewardship in veterinary settings
  • FDA approves first treatment for rare adrenal tumors
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on efforts to safeguard women’s health from deceptive health claims and significant risks related to devices marketed for use in medical procedures for “vaginal rejuvenation”
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on the process FDA is undertaking for reviewing and modernizing the agency’s standards of identity for dairy products
  • Statement from FDA Commissioner Scott Gottlieb, M.D. on voluntary recalls of Ritz, Goldfish and other products issued out of an abundance of caution

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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