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  1. Guidances | Drugs

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

Topic Guidance Status Date
Compliance Drug Products Labeled as Homeopathic Guidance for FDA Staff and Industry Final 12/7/2022
Clinical - Medical Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations Draft 12/6/2022
ICH-Safety E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical Trials Final 12/5/2022
Generics Statistical Approaches to Establishing Bioequivalence Draft 12/2/2022
Generics ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions Draft 12/2/2022
Clinical-Antimicrobial Compounding Certain Beta-Lactam Products in Shortage Under Section 503A of the Federal Food, Drug, and Cosmetic Act Final 11/18/2022
ICH-Quality Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin Draft 11/10/2022
Generics Sameness Evaluations in an ANDA — Active Ingredients Draft 11/8/2022
Clinical - Medical M10 Bioanalytical Method Validation and Study Sample Analysis Final 11/4/2022
Clinical - Medical Cross Labeling Oncology Drugs in Combination Regimens Final 11/2/2022
ICH-Safety S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals Final 11/2/2022
User Fees Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program Draft 11/1/2022
Clinical - Medical Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Trials Draft 10/31/2022
Clinical - Antimicrobial Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, and Prevention Draft 10/27/2022
Administrative/Procedural Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products Final 10/27/2022
Generics Topical Dermatologic Corticosteroids: In Vivo Bioequivalence Draft  10/21/2022
Generics In Vitro Release Test Studies for Topical Drug Products Submitted in ANDAs Draft 10/21/2022
Generics In Vitro Permeation Test Studies for Topical Drug Products Submitted in ANDAs Draft 10/21/2022
Generics Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs Draft 10/21/2022
Biostatistics Multiple Endpoints in Clinical Trials Final 10/20/2022
Clinical - Medical Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA Final 10/13/2022
Generics Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA  Final 10/5/2022
Generics Competitive Generic Therapies Final 10/5/2022
Generics Facility Readiness: Goal Date Decisions Under GDUFA Draft 10/3/2022
Pharmaceutical Quality/Chemistry, Manufacturing, and Controls (CMC) Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA Draft 10/3/2022
Pharmaceutical Quality/Chemistry, Manufacturing, and Controls (CMC) Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules Final 10/3/2022
Electronic Submissions Providing Over-the-Counter Monograph Submissions in Electronic Format Draft 9/27/2022
Administrative/Procedural Exemption and Exclusion From Certain Requirements of the Drug Supply Chain Security Act for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency Guidance for Industry Final 9/22/2022
Administrative/Procedural How To Obtain a Covered Product Authorization Draft 9/21/2022
Labeling Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug Products Draft 9/8/2022
Labeling Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products Draft 9/8/2022
Real World Data/Real World Evidence (RWD/RWE)
Administrative/Procedural		 Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products Final 9/8/2022
  E11A Pediatric Extrapolation Draft 8/26/2022
ICH-Multidisciplinary  M12 Drug Interaction Studies Draft 8/26/2022
ICH-Quality Q14 Analytical Procedure Development Draft 8/26/2022
ICH-Quality Q2(R2) Validation of Analytical ProceduresQ14 Analytical Procedure Development Draft 8/26/2022
ICH-Efficacy, ICH-Safety E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential--Questions and Answers Final 8/26/2022    
Generics In Vitro Release Test Studies for Topical Drug Products Submitted in ANDAs Draft 10/21/2022
Generics In Vitro Permeation Test Studies for Topical Drug Products Submitted in ANDAs Draft 10/21/2022
Generics Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs Draft 10/21/2022
Biostatistics Multiple Endpoints in Clinical Trials Final 10/20/2022
Clinical - Medical Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA Final 10/13/2022
Generics Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA  Final 10/5/2022
Generics Competitive Generic Therapies Final 10/5/2022
Generics Facility Readiness: Goal Date Decisions Under GDUFA Draft 10/3/2022
Pharmaceutical Quality/Chemistry, Manufacturing, and Controls (CMC) Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA Draft 10/3/2022
Pharmaceutical Quality/Chemistry, Manufacturing, and Controls (CMC) Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules Final 10/3/2022
Electronic Submissions Providing Over-the-Counter Monograph Submissions in Electronic Format Draft 9/27/2022
Administrative/Procedural Exemption and Exclusion From Certain Requirements of the Drug Supply Chain Security Act for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency Guidance for Industry Final 9/22/2022
Administrative/Procedural How To Obtain a Covered Product Authorization Draft 9/21/2022
Labeling Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug Products Draft 9/8/2022
Labeling Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products Draft 9/8/2022
Real World Data/Real World Evidence (RWD/RWE)
Administrative/Procedural		 Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products Final 9/8/2022
  E11A Pediatric Extrapolation Draft 8/26/2022
ICH-Multidisciplinary  M12 Drug Interaction Studies Draft 8/26/2022
 
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