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  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
Compounding Section 503A Bulks List Final Rule Questions and Answers Guidance for Industry (Small Entity Compliance Guide) Final 5/24/2019
Biosimilars Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations Guidance for Industry Draft 5/21/2019
Biosimilars Considerations in Demonstrating Interchangeability With a Reference Product Guidance for Industry Final 5/10/2019
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
Pharmaceutical Quality/CMC Bispecific Antibody Development Programs Draft 4/18/2019
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