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May 6, 2020

CPG Sec. 160.900 Prescription Drug Marketing Act — Pedigree Requirements under 21 CFR Part 203

Purpose This document is intended to clarify for FDA personnel and the regulated industry how the agency intends to prioritize its enforcement efforts regarding the pedigree […]
May 6, 2020

ANDAs: Stability Testing of Drug Substances and Products

Docket Number: FDA-2012-D-0938 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance recommends that abbreviated new drug applications (ANDAs) submitted under section […]
May 6, 2020

CPG Sec 120.500 Health Fraud – Factors in Considering Regulatory Action

Docket Number: None found Issued by: Guidance Issuing Office Center for Food Safety and Applied Nutrition Office of Regulatory Affairs BACKGROUND: Health Fraud products are articles […]
May 6, 2020

ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence) Guidance for Industry

Docket Number: FDA-2017-D-3101 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA) is issuing this revised draft guidance […]
May 6, 2020

Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products

Docket Number: FDA-2014-D-0248 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance provides the pharmaceutical industry […]
May 6, 2020

Adverse Event Reporting to IRBs — Improving Human Subject Protection

Docket Number: FDA-2007-D-0202 Issued by: Guidance Issuing Office Office of the Commissioner, Office of Clinical Policy and Programs, Office of Clinical Policy, Office of Good Clinical […]
May 6, 2020

GI Symptoms in Parkinson’s Disease Correlate With Less Microbial Diversity GI Symptoms in Parkinson’s Disease Correlate With Less Microbial Diversity

Gastrointestinal symptoms are more common and severe in patients with Parkinson’s disease than in controls and may relate to an altered microbiome composition and reduced microbial […]
May 6, 2020

2016 Medical Gas Container-Closure Rule Questions and Answers Guidance for Industry

Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance is intended to help small businesses better understand and comply with recently issued […]
May 6, 2020

“Toll-Free Number Labeling and Related Requirements for Over-the-Counter and Prescription Drugs Marketed With Approved Applications”

Docket Number: FDA-2012-D-0544 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance is intended to help small businesses better understand and comply […]
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