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FDA
FDA Releases Draft Guidance on Immunogenicity Studies for Biosimilar…
Last week, the US Food and Drug Administration (“FDA”) released a draft guidance which provides recommendations regarding the need…
FDA Publishes Postmarket Surveillance Best Practices
The US Food and Drug Administration (“FDA”) released a draft document, entitled Best Practices in Drug and Biological Product…
FDA Issues Draft Guidance on Patient Engagement in Medical Device Trials
The US Food and Drug Administration (“FDA”) recently published a draft guidance, entitled Patient Engagement in the Design and…
FDA Issues Four Final Guidances on 510(k) Medical Device Programs
The US Food and Drug Administration (“FDA”) recently issued four final guidance documents related to 510(k) medical device…
Pharmaceutical Manufacturers Weigh-In on OPDP Study of Drug Cancer Ads
The US Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) announced a study of oncology…
FDA Says More Orphan Drug Labels Need Pediatrics Info
The US Food and Drug Administration (“FDA”) provided a report to Congress, entitled Pediatric Labeling of Orphan Drugs, detailing…
FDA OPDP Issues Warning Letter to Galt Pharmaceuticals Regarding Insomnia…
The US Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) sent a Warning Letter to Galt…
FDA ANDA Review and Approval Metrics Improving, But Much Work Remains
The US Food and Drug Administration (“FDA”) released quarterly data on two programs intended to increase generic competition and…
Cannabidiol Confusion Continues As The FDA Weighs In
The FDA’s regulation of medicinal cannabidiol containing products is an ongoing work in progress. However, the FDA’s recent spate…
FDA Finalizes Revised Guidance on REMS Revisions and Modifications
The US Food and Drug Administration (“FDA”) finalized a revised guidance on making modifications to risk evaluation and mitigation…