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FDA
High Expectations For New Biosimilars About to Hit Market
With recent concerns about the skyrocketing cost of prescription drugs and biologics, attention has turned to whether the…
FDA to End Practice of Quarterly Reports of Approved and Denied Medical…
The US Food and Drug Administration (FDA) proposed revisions to its medical device regulations to end the practice of publishing…
FDA Draft Guidance on Demonstrating Substantial Evidence of Effectiveness…
The US Food and Drug Administration (FDA) issued draft guidance on demonstrating “substantial evidence” of effectiveness for drugs…
Court Rules FDA Exceeded Authority When It Regulated Contrast Agent As Drug
The US District Court for the District of Columbia recently ruled that the US Food and Drug Administration (“FDA”) exceeded its…
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…