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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. Read More
The FDA withdrew its draft guidance on analytical studies of biosimilars Thursday and said it plans to issue an amended version that will give sponsors “appropriate flexibility.” Read More
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. Read More
The agency will grant a waiver or reduction of one or more user fees if needed to protect public health, if the assessment would hurt innovation, or if the applicant is a small business submitting its first human drug application. Read More
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 replace the existing submission process until the fall. Read More
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sponsors seeking user fee waivers or reductions can request them in one of three categories, according to a revised draft guidance from the FDA. Read More
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 on, an agency official told the Senate HELP committee Tuesday. Read More