fbpx
October 21, 2022

Topical Dermatologic Corticosteroids: In Vivo Bioequivalence

Docket Number: FDA-2022-D-1270 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance is intended to assist applicants who submit abbreviated new drug […]
October 21, 2022

IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Clinical Recommendations

Docket Number: FDA-2021-D-1140 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance is intended for sponsor-investigators (hereafter referred to as sponsors) developing […]
October 21, 2022

IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Clinical Recommendations

Docket Number: FDA-2021-D-1140 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance is intended for sponsor-investigators (hereafter referred to as sponsors) developing […]
October 21, 2022

FDA issues final guidance about multiple endpoints in clinical trials

Today, FDA issued the Multiple Endpoints in Clinical Trials Final Guidance for Industry. This final guidance provides sponsors and review staff with the Agency’s thinking about […]
October 21, 2022

FDA issues final guidance about multiple endpoints in clinical trials

Today, FDA issued the Multiple Endpoints in Clinical Trials Final Guidance for Industry. This final guidance provides sponsors and review staff with the Agency’s thinking about […]
October 21, 2022

In Vitro Release Test Studies for Topical Drug Products Submitted in ANDAs

Docket Number: FDA-2022-D-1859 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research, Office of Regulatory Policy This guidance is intended to assist applicants who […]
October 21, 2022

In Vitro Release Test Studies for Topical Drug Products Submitted in ANDAs

Docket Number: FDA-2022-D-1859 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research, Office of Regulatory Policy This guidance is intended to assist applicants who […]
October 21, 2022

In Vitro Permeation Test Studies for Topical Drug Products Submitted in ANDAs

Docket Number: FDA-2022-D-1862 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research, Office of Regulatory Policy This guidance is intended to assist applicants who […]
October 21, 2022

In Vitro Permeation Test Studies for Topical Drug Products Submitted in ANDAs

Docket Number: FDA-2022-D-1862 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research, Office of Regulatory Policy This guidance is intended to assist applicants who […]
google.com, pub-5711488453051849, DIRECT, f08c47fec0942fa0