FDALegislativeWatch

Profile Of A Drug Safety Scandal: Avandia Appears Headed Down Familiar Path

With FDA planning an advisory committee review and Congress calling for hearings, the detection of a cardiovascular safety signal for GlaxoSmithKline's type 2 diabetes therapy Avandia has all the hallmarks of a classic drug safety scandal.

Device User Fee Reauthorization Imperative By August, HHS Official Says

FDA will begin laying off staff if Congress does not pass a medical device user fee reauthorization bill by August, according to an administration official.

Postmarket User Fees Floated At House Subcommittee Hearing

The chairman of the House subcommittee overseeing reauthorization of medical device user fees is signaling that he might push to have a portion of industry-provided funds specifically allocated for FDA postmarket activities.

Senate Passes User Fee Reauthorization With FDA/Industry Proposals Intact

Legislation reauthorizing the medical device user fee program passed the Senate May 9. Action is now needed in the House to prevent the program from expiring on September 30.

FDA Reform Bill Leaves Senate With Reduced Safety Powers But Stiffer Fines

Legislation to reauthorize FDA's user fee program and expand the agency's oversight powers on drug safety has cleared the Senate with much stronger fines than originally envisioned by the sponsors, thanks to an amendment by Sen. Charles Grassley, R-Iowa.

Generic Biologics Warning From FDA: Implementation Resources Needed

With the expectation that language to establish a generic biologics approval pathway will be included in the FDA Revitalization Act, former FDA commissioner Frank Young warned of the need for adequate resources.

Follow-On Biologics Face Negotiation Slalom After Scaling Mount PDUFA

Creation of an approval pathway for follow-on biologics appears probable after proponents attached placeholder language to the user fee reauthorization bill in the Senate, but the generic industry and their allies still face considerable challenges to enacting legislation they find favorable.

Follow-On Biologics Get Their Vehicle As Senate Schedules Mark-Up For June 13

Negotiations on creating a pathway for follow-on biologics now have a deadline after a Senate agreement that pledges the language will be included in the final version of the FDA Revitalization Act which reauthorizes FDA's user fee program.

Follow-On Biologics Get Their Vehicle As Senate Schedules Mark-Up For June 13

Negotiations on creating a pathway for follow-on biologics now have a deadline after a Senate agreement that pledges the language will be included in the final version of the FDA Revitalization Act which reauthorizes FDA's user fee program.

Follow-On Biologics, Drug Importation Get Split Decision From Bush Administration

A "Statement of Administration Policy" regarding the FDA Revitalization Act discourages attaching language that would create a pathway for the approval of follow-on biologics, but stops short of declaring such a step unacceptable.