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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sponsors seeking user fee waivers or reductions can request them in one of three categories, according to a revised draft guidance from the FDA.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
Indivior won a temporary restraining order against Dr. Reddy’s to prevent the company from rolling out its generic version of the opioid addiction treatment Suboxone (buprenorphine and naloxone) following the FDA’s approval of the generic last week. Read More
In 2014, the Combination Products Coalition called for reform of combination product regulation to improve coordination among parties involved in reviews. Read More