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Sep 09 2019

New FDA Guidances for June to August 2019

Special Interest Guidances/Information Date Posted
Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions: Guidance for Industry and Food and Drug Administration Staff – Final 30 August 2019
Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications: Guidance for Industry and Food and Drug Administration Staff – Final 30 August 2019
Guidance for Industry: Policy Related to Cranberry Products with Added Flavorings – Final 30 August 2019
Placebos and Blinding in Randomized Controlled Cancer Clinical Trials for Drug and Biological Products Guidance for Industry – Final 28 August 2019
Male Breast Cancer: Developing Drugs for Treatment: Draft Guidance for Industry – Draft 27 August 2019
CVM GFI #257 (VICH GL57) Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Marker Residue Depletion Studies to Establish Product Withdrawal Periods in Aquatic Species – Final 19 August 2019
Guidance for Industry: Converting Units of Measure for Folate, Niacin, and Vitamins A, D, and E on the Nutrition and Supplement Facts Labels – Final 15 August 2019
Osteoporosis: Nonclinical Evaluation of Drugs Intended for Treatment Guidance for Industry: Guidance for Industry – Final 14 August 2019
Child-Resistant Packaging Statements in Drug Product Labeling Guidance for Industry – Final 13 August 2019
Gastroparesis: Clinical Evaluation of Drugs for Treatment Guidance for Industry – Draft 13 August 2019
Fabry Disease: Developing Drugs for Treatment Guidance for Industry – Draft 07 August 2019
FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements: Guidance for Industry – Final 02 August 2019
Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment: Draft Guidance for Industry and Food and Drug Administration Staff – Draft 02 August 2019
“Harmful and Potentially Harmful Constituents” in Tobacco Products as Used in Section 904(e) of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry and FDA Staff – Final 02 August 2019
Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations Guidance for Industry – Final 01 August 2019
Bacterial Vaginosis: Developing Drugs for Treatment Guidance for Industry – Final 31 July 2019
E8(R1) GENERAL CONSIDERATIONS FOR CLINICAL STUDIES – Draft 31 July 2019
General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products Guidance for Industry – Draft 31 July 2019
Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers – Draft 31 July 2019
Uncomplicated Urinary Tract Infections: Developing Drugs for Treatment Guidance for Industry – Final 31 July 2019
Vulvovaginal Candidiasis: Developing Drugs for Treatment – Final 31 July 2019
Rare Pediatric Disease Priority Review Vouchers: Draft Guidance for Industry – Draft 30 July 2019
Delayed Graft Function in Kidney Transplantation: Developing Drugs for Prevention Guidance for Industry – Final 26 July 2019
Metal Expandable Biliary Stents – Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff – Final 26 July 2019
CVM GFI #181 Blue Bird Medicated Feed Labels – Final 23 July 2019
Providing Regulatory Submissions in Electronic Format–Submission of Manufacturing Establishment Information Guidance for Industry – Draft 23 July 2019
Postmarketing Safety Reporting for Combination Products: Guidance for Industry and FDA Staff – Final 22 July 2019
Submitting Next Generation Sequencing Data to the Division of Antiviral Products Guidance for Industry Technical Specifications Document – Final 18 July 2019
Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues Guidance for Industry: Draft Clinical/Medical – Draft 17 July 2019
Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for Industry – Draft 16 July 2019
Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent Pregnancy Guidance for Industry – Draft 11 July 2019
Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials: Guidance for Institutional Review Boards, Industry, Clinical Investigators, and Food and Drug Administration Staff – Final 11 July 2019
Population Pharmacokinetics – Draft 11 July 2019
Harmonizing Compendial Standards With Drug Application Approval Using the USP Pending Monograph Process Guidance for Industry – Draft 10 July 2019
Using the Inactive Ingredient Database Guidance for Industry – Draft 10 July 2019
Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry – Final 09 July 2019
Compliance Policy for Certain Compounding of Oral Oxitriptan (5-HTP) Drug Products for Patients With Tetrahydrobiopterin (BH4) Deficiency Immediately in Effect Guidance for Industry – Final 05 July 2019
Center for Devices and Radiological Health (CDRH) Appeals Processes: Guidance for Industry and Food and Drug Administration Staff – Final 02 July 2019
Center for Devices and Radiological Health (CDRH) Appeals Processes: Questions and Answers About 517A: Guidance for Industry and Food and Drug Administration Staff – Final 02 July 2019
Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry – Draft 01 July 2019
Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products — Content and Format Guidance for Industry – Draft 01 July 2019
Epidermolysis Bullosa: Developing Drugs for Treatment of Cutaneous Manifestations; Guidance for Industry – Final 28 June 2019
Marketing Clearance of Diagnostic Ultrasound Systems and Transducers : Guidance for Industry and Food and Drug Administration Staff – Final 27 June 2019
Treatment for Heart Failure: Endpoints for Drug Development Guidance for Industry – Draft 27 June 2019
Clinical Investigations for Prostate Tissue Ablation Devices: Draft Guidance for Industry and Food and Drug Administration Staff – Draft 26 June 2019
E19 OPTIMISATION OF SAFETY DATA COLLECTION – Draft 26 June 2019
M10 BIOANALYTICAL METHOD VALIDATION – Draft 26 June 2019
Draft Guidance for Industry: Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting – Draft 24 June 2019
Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs – Final 21 June 2019
Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework Guidance for Industry – Draft 20 June 2019
Guidance for Industry: Determining the Number of Employees for Purposes of the “Small Business” Definition in Parts 117 and 507 – Final 19 June 2019
Guidance for Industry: Declaration of Added Sugars on Honey, Maple Syrup, Other Single-Ingredient Sugars and Syrups, and Certain Cranberry Products – Final 18 June 2019
Mouse Embryo Assay for Assisted Reproduction Technology Devices – Draft 13 June 2019
Testing for Biotin Interference in In Vitro Diagnostic Devices: Draft Draft Guidance for Industry – Draft 13 June 2019
ANDA Submissions — Content and Format of Abbreviated New Drug Applications: Guidance for Industry – Final 12 June 2019
Applications for Premarket Review of New Tobacco Products – Draft 11 June 2019
Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems (ENDS): Guidance for Industry – Final 11 June 2019
Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry – Draft 06 June 2019
Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry – Draft 06 June 2019
Nonalcoholic Steatohepatitis with Compensated Cirrhosis: Developing Drugs for Treatment Guidance for Industry – Draft 06 June 2019
Draft Guidance for Industry: Evaluating Alternate Curricula for the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption – Draft 03 June 2019
CPG Sec. 651.100 Ethylenediamine Dihydroiodide (EDDI) – Final 01 June 2019
Upcoming Meetings (* = New)
* Vaccines and Related Biological Products Advisory Committee November 8, 2019 Meeting Announcement – 11/08/2019 – 11/08/2019
* November 6-7, 2019: General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee Meeting Announcement – 11/06/2019 – 11/07/2019
* October 30, 2019: Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee Meeting Announcement – 10/30/2019 – 10/30/2019
* October 16, 2019: Antimicrobial Drugs Advisory Committee Meeting Announcement – 10/16/2019 – 10/16/2019
* Vaccines and Related Biological Products Advisory Committee October 9, 2019 Meeting Announcement – 10/09/2019 – 10/09/2019
* September 27, 2019: Meeting of the Pediatric and Drug Safety and Risk Management Committees – 09/27/2019 – 09/27/2019
* September 26, 2019: Meeting of the Pediatric and Drug Safety and Risk Management Advisory Committees – 09/26/2019 – 09/26/2019
* September 18, 2019: Meeting of the Nonprescription Drugs Advisory Committee Meeting Announcement – 09/18/2019 – 09/18/2019
* Allergenic Products Advisory Committee September 13, 2019 Meeting Announcement – 09/13/2019 – 09/13/2019
* September 10, 2019: Patient Engagement Advisory Committee Meeting Announcement – 09/10/2019 – 09/10/2019

Last updated: 09 September 2019