- Sovaldi Wins Round Two in the Battle to be the Best-Selling Drug
- Sovaldi, a Quantum Leap… Backwards to the Days Before Randomized Controlled Trials?
Speaking of my last post and capitalism…
Posted on Tuesday 29 July 2014
Sorry, the comment form is closed at this time.
has the pharma game changed….has “deemed to be breakthrough” replaced “blockbusters?
Food and Drug Administration Safety and Innovation Act (FDASIA)
montage of images illustrating user fees, stakeholder involvement, innovation and drug safety
The Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law on July 9, 2012, expands the FDA’s authorities and strengthens the agency’s ability to safeguard and advance public health by:
Giving the authority to collect user fees from industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biological products;
Promoting innovation to speed patient access to safe and effective products;
Increasing stakeholder involvement in FDA processes; and
Enhancing the safety of the drug supply chain.
To help the public keep track of the agency’s progress on these and other provisions, we’ve established a 3-year implementation plan, which is planned to be updated on a monthly basis.
Below are just some of the accomplishments FDA has achieved since the law was passed in 2012.
http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/ucm20027187.htm
I wonder which monolithic force will win this battle.
Who Should Get Pricey Hepatitis C Drugs?
I was always taught that rationing wouldn’t happen.