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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
The CHMP working group also recommended the clarification of clinical data requirements used to support new combinations of known beta-lactam agents with new beta-lactamase inhibitors. Read More
Endo said it believes it has correctly estimated the total liability cost it faces, but the litigation could ultimately carry a bigger price tag. Read More
The European Medicines Agency proposes to merge two guidances on clinical evaluations of bacterial infection treatments to reflect the latest scientific advice from its Committee for Medicinal Products for Human Use. Read More