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FDA
Industry Reaction Mixed to FDA Draft Guidance on Real World Data and…
In May, the US Food and Drug Administration (“FDA”) released a draft guidance outlining its current thinking on real-world data…
FDA Proposes Updates to Labeling with Two Draft Guidances
The US Food and Drug Administration (“FDA”) issued two new draft guidances relating to the labeling requirements for human…
FDA Report Shows NDA and BLA Filings on the Rise in the First Quarter of FY…
The US Food and Drug Administration (“FDA”) recently published its quarterly Real Time Report on new drug application (“NDA”) and…
NECC Conspiracy Convictions Overturned on Legal Impossibility Theory
Last month, a federal judge in Boston overturned the convictions of two former employees of New England Compounding Center…
FDA Issues Enforcement Letter Regarding Eskata Risks Omitted From DTC…
The US Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) recently issued an enforcement letter…
HHS and FDA Offer Two Pathways to Drug Importation
On July 31, 2019, the United States Department of Health and Human Services (HHS), in conjunction with the Food and Drug…
New FDA Draft Guidance on Opioid Benefit-Risk Assessment Includes…
Recently, the US Food and Drug Administration (“FDA”) published a new draft guidance entitled Opioid Analgesic Drugs:…
FDA Issues Advertising Warning Letter to Vivus
The FDA’s Office of Prescription Drug Promotion (OPDP) issued its second untitled letter of the year to California drugmaker Vivus…
FDA to Study Accelerated Approval Drug DTC Marketing
The US Food and Drug Administration (“FDA”) recently published a notice in the Federal Register seeking to find out more about how…
FDA Final Guidance on Demonstrating Biosimilar Interchangeability
The FDA issued a final guidance on the pathway for interchangeable biosimilar drugs. The guidance is intended to assist sponsors…