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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
Two new FDA initiatives would promote generic competition through updated labeling and more efficient reviews, according to Commissioner Scott Gottlieb. Read More
HHS issued a final rule to once again delay implementation of the revised Common Rule on the protection of human subjects in clinical trials for six months until Jan. 21, 2019, and to permit an exception from the existing federal policy for three burden-reducing provisions during the delay period. Read More