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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
Generic Drugs 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
Administrative / Procedural Charging for Investigational Drugs Under an IND: Questions and Answers Draft 8/23/2022
ICH-Safety FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products Final 8/15/2022
Electronic Submissions Biosearch Monitoring Technical Conformance Guide Final 8/15/2022
Generics Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies Draft 8/2/2022
Pharmaceutical Quality Changes to Disposable Manufacturing Materials: Questions and Answers Guidance for Industry Final 7/29/2022
Labeling Human Prescription Drug and Biological Products--Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers--“Dose Banding” Draft 7/20/2022
Generics Evaluation of Therapeutic Equivalence Draft 7/20/2022
Labeling Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products — Content and Format Final 7/15/2022
Administrative/Procedural Identifying Trading Partners Under the Drug Supply Chain Security Act Draft 7/5/2022
Administrative / Procedural Charging for Investigational Drugs Under an IND: Questions and Answers Draft 8/23/2022
ICH-Safety FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products Final 8/15/2022
Electronic Submissions Biosearch Monitoring Technical Conformance Guide Final 8/15/2022
Generics Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies Draft 8/2/2022
Pharmaceutical Quality Changes to Disposable Manufacturing Materials: Questions and Answers Guidance for Industry Final 7/29/2022
Labeling Human Prescription Drug and Biological Products--Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers--“Dose Banding” Draft 7/20/2022
Generics Evaluation of Therapeutic Equivalence Draft 7/20/2022
Labeling Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products — Content and Format Final 7/15/2022
Administrative/Procedural Identifying Trading Partners Under the Drug Supply Chain Security Act Draft 7/5/2022
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