Public Citizen is urging the FDA to take Takeda’s Uloric and all products containing febuxostat off the market after the recent release of a post-market study claiming the gout treatment…
A New York judge refused a request by opioid manufacturers to throw out lawsuits by eight counties, ruling against defenses similar to those offered by opioid makers in pending federal…
The FDA withdrew its draft guidance on analytical studies of biosimilars Thursday and said it plans to issue an amended version that will give sponsors “appropriate flexibility.” Source: Drug Industry…
The Trump administration is proposing to change the FDA’s name to the Federal Drug Administration and shift the agency’s food programs to the U.S. Department of Agriculture according to a…
The FDA warned a Texas compounding pharmacy for lacking prescriptions for some compounded drugs and for various GMP deficiencies. Source: Drug Industry Daily
The European Medicines Agency launched its new online portal for orphan designation applications and is strongly encouraging companies to start using the portal right away, although it will not fully…
Drug and biologics sponsors seeking user fee waivers or reductions can request them in one of three categories, according to a revised draft guidance from the FDA. Source: Drug Industry…
The FDA published draft guidance to assist developers of monotherapeutic, combination and adjunctive drug treatments for major depressive disorder (MDD), offering considerations for nonclinical safety and clinical pharmacology. Source: Drug…
In its fifth annual drug shortage report to Congress, the FDA called 2017 “a challenging year” with shortages up again from 2016 despite a steady overall improvement since 2011. Source:…
HHS needs more authority to audit entities such as hospitals and clinics under the 340B drug pricing program to determine how much they save and what they spend their savings…