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Drug Shortages
FDA: Recently Signed PDUFA 5 Provisions to Address Drug Shortages
On July 9, 2012, President Obama signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA), which gives…
House Committee on Oversight and Government Reform Report: FDA’s…
The issue of drug shortages has been at the forefront over the past several months and earlier this year, FDA issued Guidance to…
FDA Reports Fewer Number of New Drug Shortages
As we have noted over the past several months, drug shortages have been causing severe problems for patients in America. Drug…
FDA: PFUFA – Senate Introduces Bi-Partisan Legislation on Drug…
There has been a tremendous amount of attention surrounding drug shortages in the U.S. over the past several months—and rightly…
Increasing Generic Drug Shortages Linked to Government Price Controls
As we previously noted, the Food and Drug Administration (FDA) recently released guidance to industry regarding the reporting of…
FDA Guidance Notification of Prescription Drug or Biologic Product Drug…
There have been significant media coverage and government oversight surrounding drug shortages over the past few months. On…
Drug Shortages Potential Causes Stricter FDA, Price Controls and Policies…
Over the past two years shortages have developed for over 180 drugs, including cancer treatments. According to a recent article…
Shortage of Injection Treatments Looms over ACA
As the Obama Administration and federal agencies begin preparing for implementation of key provisions of the Affordable Care Act…
Swine Flu Who is the Responsibility for the Vaccine Shortage
As many individuals and families are dealing with the shortage of H1N1 vaccine’s, this week I searched online and found several…