Industry News
Premarket Submissions for Non-Clinical Bench Performance Testing
Do you know the content and format requirements for submitting Premarket Submissions for Non-Clinical Bench Performance Testing? Recent FDA guidance describes the relevant information that should be included in test report summaries, test protocols and complete test...
Quality Requirements for Drug-Device Combinations
(From European Medicines Agency): Guidance is provided on dossier requirements for drug-device combinations (DDCs) in the context of a regulatory submission (marketing authorisation application and post-authorisation application). The types of DDCs within the scope of...
FDA: Initiation of Voluntary Recalls
From the Federal Register, Wednesday, April 24, 2019: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and FDA staff entitled ‘‘Initiation of Voluntary Recalls Under 21 CFR part 7, subpart C.’’ The draft...
InDevR Gains Market Clearance for Influenza A+B Assay
(From FDA Device News) The FDA granted InDevR 510(k) clearance for its FluChip-8G influenza diagnostic test, an assay that can identify multiple non-seasonal viruses. The in vitro diagnostic test qualitatively detects and distinguishes between several influenza A...
FDA Classifies Suitable Accessories into Class I as Required by the FDA Reauthorization Act of 2017
The Food and Drug Administration (FDA) is classifying suitable accessories into class I as required by the FDA Reauthorization Act of 2017 (FDARA). The Agency has determined that general controls alone are sufficient to provide reasonable assurance of safety and...
Pharmaceutical and Medical Device Recalls – Statistics and Facts (Statista.Com)
A product recall occurs when safety issues or defects in a product are found that might endanger consumers, or put the producer or seller at risk of legal action. When this happens, the product is taken off the market resulting in financial loss for the producing...
Reimagining Quality Operations In The Life Sciences
Are you looking for better ways to achieve cross-functional ownership of quality? Would you like to improve the efforts of the CQO team in building quality, resulting in the creation of formal degree programs and other innovative solutions? This article...
FDA’s New Data Integrity Guidance — Highlights & Observations
The scope of the FDA document includes drugs, biologics, and positron emission tomography drugs. The agency also states the requirements are consistent with the requirements in ICH Q7, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, thus...