The Creating and Restoring Equal Access to Equivalent Samples Act, or CREATES Act for short, was introduced earlier this year to try and end abusive delay tactics used by brand-name drug manufacturers to block the [...]
Last week, the FDA released a draft guidance document aimed at improving the treatment situation for pediatric patients suffering from rare diseases. The guidance, titled “Pediatric Rare Diseases—A Collaborative Approach for Drug Development Using Gaucher [...]
A report released by health economists at Brigham and Women's Hospital in Boston shows that some FDA programs are more successful than others at shortening the time taken to get drugs from early clinical trials [...]
FDA Commissioner, Scott Gottlieb, has announced that the agency will be releasing new guidance that will help bring more complex generic drugs to market. The guidance will focus on generic treatments that combine a drug [...]