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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
Senate Republicans have introduced a bill to roll back measures in the Inflation Reduction Act that permit Medicare to negotiate drug prices and cap annual drug expenses for seniors at $2,000 a year. Read More