Pharma Specialists

Draft Guidance

Content and Format of the Dosage and Administration Section of Labeling

This guidance is intended to assist applicants in developing the…

January 14, 2023

Draft Guidance

Physicochemical and Structural (Q3) Characterization of Topical Drug Products

This guidance is intended to assist applicants who are submittin…

December 11, 2022

Bioequivalence Study

Statistical Approaches to Establishing Bioequivalence

The FDA draft guidance on 'Statistical Approaches to Establi…

December 02, 2022

Draft Guidance

Benefit-Risk Considerations for Product Quality Assessments

Before approving an application, FDA must determine whether the …

November 18, 2022

Clinical Trials

Ethical Considerations for Clinical Investigations of Medical Products Involving Children

FDA recently published a draft guidance on Ethical Consideration…

October 18, 2022

Draft Guidance

Facility Readiness and Goal Date Decisions

This guidance provides information to applicants on how FDA inte…

October 09, 2022

Automation

Computer Software Assurance for Production and Quality System Software

FDA is issuing this draft guidance to provide recommendations on…

September 23, 2022

Draft Guidance

Evaluation of Therapeutic Equivalence | FDA Guidance for Industry

This guidance explains FDA’s therapeutic equivalence evaluations…

July 22, 2022

Draft Guidance

Analytical Procedures for mRNA Vaccine Quality | USP Draft Guidelines

Suggested audience: Suppliers and manufacturers of mRNA vaccine…

June 18, 2022