Tag Archives: FDASIA

FDA Final Rule Mandates Drug Manufacturer Notification of Impending Drug Shortages

On July 8, 2015, the federal Food and Drug Administration (FDA) published a final rule requiring drug manufacturers to report to the Agency any supply chain disruptions that could lead to drug shortages. The final rule implements provisions of the Food and Drug Administration Safety and Innovation Action of 2012 (FDASIA) (Pub. L. No. 112-144). … Continue Reading

FDA Revises Guidance Defining Delays, Denials, Limits and Refusals of a Drug Inspection

The Food and Drug Administration (FDA) recently issued a notice announcing the Agency's revised guidance for industry defining the types of action, inaction, and circumstances that FDA considers to constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection for the purposes of making a drug adulterated. The revised guidance clarifies FDA's expectations regarding the types of action, inaction, and circumstances that make a drug adulterated under FDASIA and the FD&C Act. FDA also provides examples that constitute reasonable explanations for actions, inactions, or circumstances that could otherwise be considered delaying, denying or limiting inspection, or refusing to permit entry or inspection.… Continue Reading

Expedited Drug Development and Review: New FDA Resource Now Available

A new guidance entitled “Expedited Programs for Serious Conditions – Drugs and Biologics” is now available from the Food and Drug Administration (FDA). The 40-page guidance is intended to serve as a single resource for information on FDA’s policies and procedures related to its four expedited drug development and review programs: (1) fast track designation, (2) … Continue Reading

FDA Proposal Amends Medical Device Classification Rules

On March 25, 2014, the Food and Drug Administration (FDA) published a proposal to amend its regulations governing the classification and reclassification of medical devices. In addition to conforming the regulations to recent changes made by the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA), the proposed rule makes changes unrelated to FDASIA. … Continue Reading

Congressional Hearings Focus on HealthCare.gov Enrollment, Other Policy Issues

Congressional committees continue to focus on the experience of consumers and insurers since the HealthCare.gov insurance portal launched on October 1, along with potential issues related to the security of personal data transmitted through the site. For instance, House hearings this week include an Oversight and Government Reform Committee hearing on “ObamaCare Implementation: The Rollout … Continue Reading

FDA Addresses Food and Drug Administration Safety and Innovation Act (FDASIA) Implementation

On November 19, 2012, the Food and Drug Administration (FDA) published a notice and an amendment to a proposed rule related to FDA’s implementation of the FDASIA, which was signed into law on July 9, 2012. In the notice, FDA announced that it is seeking information from all stakeholders (including patients, physicians, dentists, and manufacturers) … Continue Reading
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