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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
The ICH guidance includes 41 questions addressing the scope of ICH S9, studies needed to support nonclinical evaluations, nonclinical data to support clinical trial design and marketing, among other issues. Read More
There was “a great deal of uncertainty in the available evidence of clinical effectiveness compared to existing treatments,” said Meindert Boysen, director of NICE’s center for technology evaluation. Read More
Americans’ trust in drugmakers plunged in the past year to the lowest level since Edelman launched its annual Trust Barometer survey five years ago. Read More