Recently Issued Guidance Documents

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• Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices
  CDRH/CBER/ORA, November 2019

• Electronic Submission of IND Safety Reports Technical Conformance Guide; Guidance for Industry
  CDER/CBER/OCE, October 2019

• Providing Regulatory Submissions in Electronic Format: IND Safety Reports; Draft Guidance for Industry
  CDER/CBER/OCE, October 2019

• Drug Products Labeled as Homeopathic; Draft Guidance for FDA Staff and Industry
  CDER/CBER, October 2019

• Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry
  CDER/CBER, October 2019

• Drug Master Files; Draft Guidance for Industry
  CDER/CBER, October 2019

• Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER Questions and Answers; Guidance for Industry
  CDER/CBER, October 2019

• Submitting Study Datasets for Vaccines to the Office of Vaccines Research and Review: Guidance For Industry; Technical Specifications Document
  CBER, October 2019

• Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination; Guidance for Industry
  CDER/CBER/CDRH, October 2019

• Further Testing of Donations that are Reactive on a Licensed Donor Screening Test for Antibodies to Hepatitis C Virus; Guidance for Industry
  CBER, October 2019

• Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Guidance for Industry
  CBER, September 2019

• Clinical Decision Support Software; Draft Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER/CDER,  September 2019

• Providing Regulatory Submissions for Medical Devices in Electronic Format — Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, September 2019

• The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program; Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff
  CDRH/CBER, September 2019

• Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders
  CDRH/CBER, September 2019

• Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment Guidance for Industry; Guidance for Industry
  CDER/CBER, September 2019

• Wholesale Distributor Verification Requirement for Saleable Returned Drug Product—Compliance Policy; Guidance for Industry
  CDER/CBER/ORA, September 2019

• Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products; Draft Guidance for Industry
  CBER/CDER, September 2019

• Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, September 2019

• Safer Technologies Program for Medical Devices: Draft Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, September 2019

• Refuse to Accept Policy for 510(k)s; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, September 2019

• The Abbreviated 510(k) Program; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, September 2019

• The Special 510(k) Program; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, September 2019

• Format for Traditional and Abbreviated 510(k)s; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, September 2019

• User Fees and Refunds for De Novo Classification Requests; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, September 2019

• Acceptance Review for De Novo Classification Requests; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, September 2019

• FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, September 2019

• Humanitarian Device Exemption (HDE) Program; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, September 2019

• Placebos and Blinding in Randomized Controlled Cancer Clinical Trials for Drug and Biological Products; Guidance for Industry
  CDER/CBER, August 2019

• Male Breast Cancer: Developing Drugs for Treatment; Draft Guidance for Industry
  CDRH/CBER, 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
  CDRH/CBER,  August 2019

• Child-Resistant Packaging Statements in Drug Product Labeling; Guidance for Industry
  CDER/CBER, August 2019

• Fabry Disease: Developing Drugs for Treatment; Draft Guidance for Industry
  CDER/CBER, August 2019

• Bacterial Vaginosis:  Developing Drugs for Treatment; Guidance for Industry
  CDER/CBER, August 2019

• Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers; Draft Guidance for Industry
  CDER/CBER/CDRH/CVM/CFSAN/CTP, July 2019

• Delayed Graft Function in Kidney Transplantation: Developing Drugs for Prevention; Guidance for Industry
  CDER/CBER, July 2019

• Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications; Draft Guidance for Industry
  CDER/CBER, July 2019

• Risk Evaluation and Mitigation Strategies: Modifications and Revisions; Guidance for Industry
  CDER/CBER, July 2019

• Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products – Content and Format; Draft Guidance for Industry
  CDER/CBER, 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; Draft Guidance for Industry
  OCP/CDER/CBER,  July 2019