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April 17, 2020

Coronavirus (COVID-19) Update: Daily Roundup April 17, 2020

For Immediate Release: April 17, 2020 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
April 17, 2020

FDA Approves First Targeted Treatment for Patients with Cholangiocarcinoma, a Cancer of Bile Ducts

For Immediate Release: April 17, 2020 Today, the U.S. Food and Drug Administration granted accelerated approval to Pemazyre (pemigatinib), the first treatment approved for adults with […]
April 17, 2020

Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for Industry

Docket Number: FDA-2014-N-1006 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Office of Medical Products and Tobacco, […]
April 17, 2020

S9 Nonclinical Evaluation for Anticancer Pharmaceuticals–Questions and Answers

Docket Number: FDA-2016-D-2569 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Office of Medical Products and Tobacco, […]
April 17, 2020

S5B Detection of Toxicity to Reproduction for Medicinal Products: S5(R2) Detection of Toxicity to Reproduction for Medicinal Products Toxicity to Male Fertility In November 2005, the ICH incorporated the S5B addendum with S5A and retitled the combined

Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research This text is an addendum to the ICH Tripartite […]
April 17, 2020

Repeal of Section 507 of the Federal Food, Drug and Cosmetic Act _1

Docket Number: FDA-1998-D-0864 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Section 125 of Title I of […]
April 17, 2020

S5A Detection of Toxicity to Reproduction for Medicinal Products S5(R2) Detection of Toxicity to Reproduction for Medicinal Products Toxicity to Male Fertility In November 2005, the ICH incorporated the S5B addendum with S5A and retitled the combined

Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research There is a considerable overlap in the methodology that […]
April 17, 2020

Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities

Docket Number: FDA-2014-D-1524 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research This guidance sets forth the FDA’s […]
April 17, 2020

Regulatory Classification of Pharmaceutical Co-Crystals

Docket Number: FDA-2011-D-0800 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research This guidance provides applicants planning to […]
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