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FDA
OPDP Sends Warning Letter to Alkermes
Recently, the United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) sent a warning letter…
FDA Did Not Verify Whether Opioid-Curbing Effort Worked
According to a study recently published in JAMA Internal Medicine, the Food and Drug Administration (FDA) did not verify whether a…
GAO Report on Access to REMS Drugs Shows Mixed Views on Path Forward
The GAO recently published a report, entitled Generic Drug Development – Stakeholders’ Views of Risk Evaluation and Mitigation…
HHS and FDA Unveil Proposed Rules on Drug Importations
On December 18, 2019, the United States Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA)…
FDA Guidance on Adaptive Clinical Trials Design
The US Food and Drug Administration (FDA) last week finalized guidance on adaptive clinical trial designs for drugs and biologics.…
FDA Releases Report on Drug Shortages and Encourages Manufacturer Quality…
The Food and Drug Administration (“FDA”) Drug Shortages Task Force recently released a report, entitled Drug Shortages: Root…
FDA Releases Draft Guidance on Immunogenicity Studies for Biosimilar…
Last week, the US Food and Drug Administration (“FDA”) released a draft guidance which provides recommendations regarding the need…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FDA Issues Draft Guidance on Patient Engagement in Medical Device Trials
The US Food and Drug Administration (“FDA”) recently published a draft guidance, entitled Patient Engagement in the Design and…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…