|
FDA Urged to Set Comparative Effectiveness Standard(6/15/09) FDA should help any new federal comparative effectiveness research
agency by establishing written guidelines about when information is sufficiently rigorous to lead to action by other government
entities. That’s the view of American Enterprise Institute resident fellow Scott Gottlieb, a former FDA deputy
commissioner, and regulatory attorney Coleen Klasmeier (Sidley Austin). Read More
8:32 am
FTC Reiterates Follow-on Marketing Recommendations(6/15/09) FTC commissioner Pamela Jones Harbour told a 6/11 House subcommittee
hearing that pioneer biologic drug manufacturers are unlikely to need additional incentives to continue to innovate in the
face of entry of follow-on biologics beyond existing patent protection and market-based pricing. Harbour presented findings
from a recent FTC report on follow-on biologics (see story) to a House Energy and Commerce Subcommittee on Health hearing. Read More
8:09 am
Waxman Calls for Quick Follow-on Pathway Implementation6/9/09) House Energy and Commerce Committee chairman Henry Waxman (D-CA) says
that when his “Promoting Innovation and Access to Life-saving Medicine Act” (H.R. 1427), which provides a way
for FDA to approve generic biologic drugs, passes, it will be important for FDA to begin implementing the program as soon
as possible. Read More
8:32 am
Schultz: We Need to Build 510(k) Trust Back Up(6/5/09) Faced with growing criticism over alleged abuses under the 510(k) medical device program,
CDRH plans on using communication, transparency and fine tuning to build back trust in the system. Speaking at the Medical
Device Manufacturers Association’s annual meeting in Washington, DC 6/2, Center director Dan Schultz said the agency
and industry have not done a very good job of communicating to the public that the 510(k) process is not a “mindless
rubberstamp that some people are making it out to be.” Read More
3:26 pm
FDA Taking ‘Serious, Clear-eyed Look’ at Transparency(6/2/09) In announcing a new executive-level internal FDA task force on transparency
6/2, FDA commissioner Margaret Hamburg and principal deputy commissioner Joshua Sharfstein carefully avoided making any references
to specific past incidents in which the agency has not been viewed as transparent. They acknowledged that there have been
past criticisms, but said their action was part of the Obama administration’s dedication to a greater openness in government
and a desire to take a “fresh look” at what information can be made available and the best way to do so. Read More
8:05 pm
FDA and Centocor Warn on Simponi Fungal Infections(6/1/09) Centocor Ortho Biotech and FDA are warning healthcare professionals
about serious fungal infections associated with TNF-αlpha blockers, including Simponi (golimumab). Read More
6:29 am
|
|
 |
|
| We bring the FDA to you |
|
|
| click image to view available FDA meetings |
Our Subscription Newsletters:
|
|
| Daily FDA and Industry Regulatory and Compliance News |
|
|
| The most authoritative FDA news analysis each month |
|
|
| Weekly easy to ready news capsules |
|
