by anickow | Feb 19, 2012 | Commentary
This year marks the 20th anniversary of the Prescription Drug User Fee Act (PDUFA).[1] In response to a sluggish drug approval process and inadequate congressional funding of the FDA’s research and development arms, Congress passed the PDUFA to create an additional...
by josephcl | Jan 25, 2012 | Commentary
For online poker aficionados, April 15, 2011, the so-called “Black Friday” is a date that lives in infamy. For those who are unfamiliar with the event, on Black Friday the owners of the three largest poker sites in the United States (PokerStars, Absolute Poker, and...
by nsehic | Jan 25, 2012 | Commentary, Technology
This past Tuesday, the Supreme Court heard lively oral arguments in FCC v. Fox Television Stations, Inc. (No. 10-1293) addressing the constitutionality of the Federal Communications Commission’s (FCC) authority to regulate “indecency” on broadcast television. ...
by Liza Roe | Dec 17, 2011 | Commentary
This summer, the FDA issued a draft guidance document addressing how the agency intends to apply its regulatory authority to Mobile Medical Applications (MMAs). The guidance document defines mobile applications as “software applications that can be executed (run) on a...
by drlund | Dec 7, 2011 | Commentary, Legislation/Regulations
The first, and often only, financial concern of research participants is how much they are getting paid for participation. In studies that do nothing more than measure reaction time to identify a number in a serial string of letters, there is little reason to be...
