U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Guidance, Compliance, & Regulatory Information
  4. Guidances (Drugs)
  5. Newly Added Guidance Documents
  1. Guidance, Compliance, & Regulatory Information

Newly Added Guidance Documents

Newly Added Guidance Documents

Below is a sortable list of the most recently added Guidance Documents.

You can sort alphabetically by: Category/Subject Area; Guidance Title; Guidance Type (Draft or Final) and also sort by the Date the Guidance was issued.

 

Newly Added Guidance Documents

Category Title Type Issue date
Biosimilars Considerations in Demonstrating Interchangeability With a Reference Product Guidance for Industry Final 5/10/2019
Generics Determining Whether to Submit an ANDA or a 505(b)(2) Application  Final 5/9/2019
Clinical Pharmacology; Over the Counter Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-The -Counter Monograph: Study Elements and Considerations   Final 5/9/2019
Pharmacology/Toxicology Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations     Final 5/9/2019
Clinical/Medical Clinical Lactation Studies: Considerations for Study Design     Draft 5/8/2019
Clinical/Medical Postapproval Pregnancy Safety Studies Guidance for Industry     Draft 5/8/2019
Clinical/Medical Submitting Documents Utilizing Real-World Data and Real-World Evidence to FDA for Drugs and Biologics     Draft 5/8/2019
Clinical/Medical Attention Deficit Hyperactivity Disorder: Developing Stimulant Drugs for Treatment     Draft 5/3/2019
Biostatistics Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics with Continuous Outcomes    Draft 4/24/2019
Procedural Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles Final 4/24/2019
Drug Safety REMS: FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary Final 4/4/2019
Labeling Pediatric Information Incorporated Into Human Prescription Drug and Biological Products Labeling Good Review Practice Final 3/27/2019
Rare Diseases Rare Diseases: Natural History Studies for Drug Development Draft 3/22/2019
Clinical / Medical Pediatric HIV Infection: Drug Development for Treatment Final 3/19/2019
Clinical / Antimicrobial Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis Final 3/19/2019
Procedural A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Draft 3/14/2019
Clinical / Medical Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products Final 3/15/2019
Pharmacology / Toxicology Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals Guidance for Industry Final 3/15/2019
Clinical / Medical Cancer Clinical Trial Eligibility Criteria: Brain Metastases Draft 3/13/2019
Clinical / Medical Cancer Clinical Trial Eligibility Criteria: Minimum Age for Pediatric Patients Draft 3/13/2019
Clinical / Medical Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus Infections Draft 3/13/2019
Clinical / Medical Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials Draft 3/13/2019
Labeling Nonproprietary Naming of Biological Products: Update Guidance for Industry Draft 3/8/2019
Compounding Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act  Final 3/4/2019
Pharmaceutical Quality / CMC Pharmaceutical Quality/Manufacturing Standards (CGPM) Quality Considerations for Continuous Manufacturing Draft 2/27/2019
Clinical Pharmacology Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations Draft 2/26/2019
Clinical Pharmacology Bioavailability Studies Submitted in NDAs or INDs – General Considerations Draft 2/26/2019
Clinical / Medical Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products Draft 2/22/2019
Generics Competitive Generic Therapies Draft 2/19/2019
Procedural CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality Draft 2/14/2019
Clinical / Medical Opioid Use Disorder: Developing Depot Buprenorphine Products for Treatment Final 2/7/2019
Clinical / Medical Eosinophilic Esophagitis: Developing Drugs for Treatment Guidance for Industry  Draft 2/6/2019
Combination Products Principles of Premarket Pathways for Combination Products: Draft Guidance for Industry and FDA Staff Draft 2/6/2019
Clinical / Antimicrobial Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices: Guidance for Industry and Food and Drug Administration Staff Final 2/1/2019
Rare Diseases Rare Diseases: Common Issues in Drug Development Guidance for Industry Draft 2/1/2019
Procedural Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act Draft 1/31/2019
Electronic Submissions Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Final 1/29/2019
Procedural REMS Assessment: Planning and Reporting Draft 1/24/2019
Procedural Survey Methodologies to Assess REMS Goals That Relate to Knowledge Draft 1/24/2019
Pharmaceutical Quality/CMC Immunogenicity Testing of Therapeutic Protein Products —Developing and Validating Assays for Anti-Drug Antibody Detection Final 1/23/2019
Labeling Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway Final 1/22/2019
International Council for Harmonisation - Safety S11 Nonclinical Safety Testing in Support of Development of Paediatric Medicines Draft 1/22/2019
Generics ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs Final 1/16/2019