House Oversight Committee’s diatribe against Mylan has been fueled by the company’s efforts to engage lawmakers to advance its business interests, Rep. Mulvaney tells CEO Bresch: 'You asked for it.'
Mylan Pharmaceuticals Inc. invited the painful scrutiny it is receiving from Congress over the pricing if its EpiPen emergency allergy treatment by engaging with legislators to pass laws that advance its business interests, Rep. Mick Mulvaney, R-SC, told CEO Heather Bresch at a House Oversight & Government Reform Committee hearing Sept. 21.
The hearing was the first to be held on Mylan’s pattern of large price increase for EpiPen (epinephrine auto injector)...
Exploring How Everyday Industrial Compounds Enter Our Systems, Their Health Implications, and the Ongoing Quest for Safer Alternatives .
With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.
The agency also should explain the potential consequences for sponsors if enrollment goals are not met, stakeholders say in comments on the DAP draft guidance. Some commenters urged the FDA to apply waiver criteria flexibly, especially for rare diseases.
The US FDA commissioner also said the hub is looking for an executive director who will work with the CBER and CDER heads, who will serve as co-leads.
Brazil has also published its recent regulatory reliance regulations in English, a move designed to increase confidence in its decisions as it presses on with aligning its national practices with global best practices.
The US FDA commissioner also said the hub is looking for an executive director who will work with the CBER and CDER heads, who will serve as co-leads.
The FDA and sponsors of two new accelerated approval drugs for PBC have taken steps in study design, initiation and reporting transparency to ensure timely completion; Intercept’s COBALT trial of obeticholic acid was negatively impacted by product safety labeling changes and a high crossover rate to commercial drug.
