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Companies submitting or holding drug applications who plan to implement a chemistry, manufacturing, and controls (CMC) postapproval change may gain faster agency reviews using a comparability protocol (CP), according to a final guidance the FDA released on Thursday. Read More
After years of legal wrangling, the FDA is still grappling with the issue of how exactly to define “exclusivity” in its orphan drug program, according to one senior agency official who says legislative action may be needed to end the debate. Read More
COVID-19 exposed supply chain problems that should have pharmaceutical manufacturers rethinking their standard procedures — from sourcing manufacturing materials to getting completed product safely into customer hands, — says one regulatory compliance expert. Read More
The FDA has settled litigation by the Outsourcing Facilities Association (OFA) accusing the agency of unlawfully delaying the inclusion of new bulk substances on its approved list of ingredients for compounding. Read More
To achieve more diverse clinical trial participation, trial sponsors and sites should be offered incentives and rewards for recruiting more participants from underrepresented groups, according to a pair of researchers who say current legislative and regulatory efforts aren’t enough. Read More
The European Medicines Agency (EMA) has endorsed an International Council for Harmonization (ICH) guideline on testing to determine whether pharmaceuticals contain cancer-causing agents. Read More
In a preliminary opinion, the European Commission told Teva Pharmaceuticals that it suspects the Israeli drugmaker breached EU antitrust law by engaging in anticompetitive practices to delay competition for its blockbuster multiple sclerosis (MS) drug Copaxone (glatiramer). Read More