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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
ICH - Multidisciplinary M11 Template: Clinical Electronic Structured Harmonised Protocol Draft 12/21/2022
ICH - Multidisciplinary M11 Technical Specification: Clinical Electronic Structured Harmonised Protocol Draft 12/21/2022
ICH - Multidisciplinary M11 Clinical Electronic Structured Harmonised Protocol Draft 12/21/2022
Generic Drugs Controlled Correspondence Related to Generic Drug Development Draft 12/21/2022
Labeling Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims Final 12/15/2022
Clinical-Antimicrobial Pulmonary Tuberculosis: Developing Drugs for Treatment Draft 12/14/2022
Generics Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe Guidance for Industry Final 12/14/2022
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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