USA – FDA asks manufacturers to develop risk management plans to avert shortages

The US Food and Drug Administration (FDA) has issued draft guidance that spells out which types of drugs and medical devices are vulnerable to...

Canada – Update : Validation rules for regulatory transactions provided to Health Canada in...

Health Canada has updated the validation rules for regulatory transactions submitted in the non-eCTD format. These rules are built in accordance with the information...

USA – FDA updates guidance on evaluating out-of-specification results for drugs

The US Food and Drug Administration (FDA) has revised its 16-year-old final guidance on procedures for reviewing out-of-specification (OOS) results in the laboratory, including...

USA – FDA works to advance real-world data collection in pregnancy and lactation

The US Food and Drug Administration (FDA) is working on ways to facilitate greater use of real-world data (RWD) to help understand the safety...

USA – FDA guidance explains benefit-risk approach for quality assessments

The US FDA released new draft guidance yesterday discussing, among other challenges, how unresolved product quality issues might be addressed in the context of...

USA – FDA launches program to speed up rare disease drug development

FDA announced on May 10, 2022 that its Center for Drug Evaluation and Research (CDER) has launched a new program to increase and speed...
New Report Compares FDA Quality System Requirements With ISO 13485:2016

USA – FDA offers insight into product quality assessment principles

The US Food and Drug Administration (FDA) has issued draft guidance outlining its benefit-risk principles when evaluating product quality assessments for new drug applications...

USA – FDA sheds light on conducting human radiolabeled mass balance studies

The US Food and Drug Administration (FDA) has issued draft guidance outlining the clinical pharmacology considerations for human radiolabeled mass balance studies for investigational...

USA – FDA offers guidance on drug development for ulcerative colitis, Crohn’s disease

The US Food and Drug Administration (FDA) issued draft guidance documents on drug development for ulcerative colitis (UC) and Crohn’s disease, outlining recommendations on...

USA – FDA finalizes electronic postmarketing safety reporting guidance

The US Food and Drug Administration (FDA) has finalized guidance that outlines how postmarketing safety reports for drugs and biologics should be submitted electronically....

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