The FDA should avoid duplicating existing requirements in its updated guidance on chemistry, manufacturing and controls information for biologics, according to PhRMA and several drugmakers in comments to the agency.…
The FDA issued guidance for sponsors developing chronic obstructive pulmonary disease (COPD) treatments, clarifying how to efficiently use the St. George’s Respiratory Questionnaire a patient-reported outcome measure assessment tool. Source:…
The prices of 20 top-selling branded drugs increased at 10 times the price of inflation from 2012 to 2017, according to a new report released by Sen. Claire McCaskill (D-Mo.).…
The FDA hit Kolmar Korea with a Form 483 over numerous violations — including negligent handling of documents, lack of employee training and failure to conduct process validation — after…
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended six medicines, including an orphan drug, for approval at its March meeting, in addition to three recommendations for…
The FDA last week previewed an upcoming pilot project that offers initial reviews of protocols for clinical trials with highly complex, innovative designs. Source: Drug Industry Daily
In what Commissioner Scott Gottlieb called “a significant milestone” in the FDA’s new policy for oversight of drug compounding , the agency released draft guidance Friday on how it will…
Endo International and two other drugmakers agreed to pay $270.8 million to settle class-action lawsuits over a pay-for-delay arrangement for a generic of Endo’s Lidoderm lidocaine pain patch. Source: Drug…
The House passed its version of federal right-to-try legislation, sending it for re-consideration by the Senate, which passed a similar bill last August. Source: Drug Industry Daily
The House passed an omnibus spending bill Thursday that boosts FDA funding by $135 million for fiscal 2018 for a total of $2.9 billion in discretionary spending. Source: Drug Industry…