Archive for June 2018

In the coming weeks, CDER will publish online a list of surrogate endpoints that led to the approval of oncology drugs and biologicals for the first time, FDA Commissioner Scott Gottlieb announced at the National Comprehensive Cancer Network Policy Summit in Washington, D.C. Source: Drug Industry Daily

In an effort to provide potential sponsors advice on critical topics for early drug development, CBER launched its Initial Targeted Engagement for Regulatory Advice on CBER Products (INTERACT) meetings program. Source: Drug Industry Daily

The FDA approved Ferring Pharmaceuticals’ NDA for Nocdurna (desmopressin), a nocturia treatment, rejecting petitions from Serenity Pharmaceuticals and Avadel requesting that it deny the application. Source: Drug Industry Daily

Representatives from the FDA and the European Medicines Agency discussed further opportunities for collaboration in their 2018 annual meeting last week. Source: Drug Industry Daily

For the second consecutive week, the House of Representatives passed a slew of bills addressing the opioid crisis, including one on Friday directing the FDA to assess non-addictive treatment options. Source: Drug Industry Daily

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 poses serious risks to patients and offers no unique benefits compared to other lower-risk medications. Source: Drug Industry Daily

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 litigation. Source: Drug Industry Daily

The FDA withdrew its draft guidance on analytical studies of biosimilars Thursday and said it plans to issue an amended version that will give sponsors “appropriate flexibility.”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 Daily

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 broad government reform plan released yesterday. Source: Drug Industry Daily

The FDA warned a Texas compounding pharmacy for lacking prescriptions for some compounded drugs and for various GMP deficiencies. Source: Drug Industry Daily