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Rep. Keith Ellison (D-Minn.) questioned the appointment of CVS Caremark vice president and former Pfizer executive Daniel Best to oversee HHS drug pricing reforms in a letter to Secretary Alex Azar. Read More
Sens. Elizabeth Warren (D-Mass.) and Patty Murray (D-Wash.) prodded the White House to say what it’s doing to implement the 56 recommendations issued in November by the President’s Commission on Combating Drug Addiction and the Opioid Crisis. Read More
The FDA adopted an addendum updating the ICH’s E11 guideline on pediatric clinical trials, outlining ethical considerations, age classifications, pediatric drug formulations, practicalities in clinical trials and approaches to optimizing drug development. Read More
None of the 10 largest U.S. drugmakers have lowered prescription drug prices as a result of the tax reform passed in 2017, according to an analysis from the office of Sen. Cory Booker (D-N.J.). Read More
The European Commission issued revised guidance for regulatory authorities, marketing authorization applicants and holders on the listing of excipients on product labeling and package leaflets. Read More
The FDA issued two guidances on postmarketing safety reporting for combination products, pushing back reporting requirements for certain combination products and clarifying reporting rules for their constituent parts. Read More
The House passed an omnibus spending bill on March 22 that boosts FDA funding for medical product safety activities by $113.2 million, including a one-time payment of $94 million to expand FDA’s surveillance efforts at international mail facilities to address the opioid crisis. Read More
The U.K.’s Medicines and Healthcare products Regulatory Agency released new guidance on its approach to GXP data integrity and its expectations for achieving compliance. Read More