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…
The FDA warned Tris Pharma for manufacturing adulterated products at its Monmouth Junction, New Jersey facility, citing failures to properly investigate product defects and other deficiencies found during a March…
The FDA denied Insys Therapeutics’ petition asking the agency to reject abbreviated new drug applications for generics of Syndros (dronabinol) oral solution that rely on a waiver instead of establishing…
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…
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…
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…
HHS should claim five patents on Serepta Therapeutics’ Exondys 51 (eteplirsen), a drug used to treat Duchenne muscular dystrophy, and use the patents as leverage to lower the drug’s price,…
CDER’s Office of New Drugs issued a new manual of policies and procedures, effective immediately, concerning NDAs for parenteral drugs that will be packaged in plastic immediate containers. Source: Drug…
The FDA published a new draft guidance outlining how early sponsors should incorporate pediatric patients, and the relevant age groups, for systemic therapies for atopic dermatitis. Source: Drug Industry Daily
FDA drug fraud investigations increased by nearly 50 percent in fiscal 2017 reaching an all-time high since the agency began participating in the Health Care Fraud and Abuse Control Program…