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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
After a flurry of opioid- related bills passed the House earlier last week, the chamber on Friday passed legislation that will limit the availability of synthetic drugs. Read More
Sen. Orrin Hatch (R-Utah) proposes to amend the landmark Hatch-Waxman Act to require generic drugmakers challenging brand patents to choose between inter partes reviews or Hatch-Waxman litigation. Read More