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User Fees

June 22, 2012 | Daily News

Companies developing mobile medical applications are pleased lawmakers left out of the final FDA user fee legislation a contentious Senate provision that would have slowed up FDA's issuance of a final mobile app guidance by requiring an outside working group first report to Congress on a proposed regulatory framework.

June 22, 2012 | Daily News

BOSTON -- Stakeholders involved in down-to-the-wire negotiations aimed at crafting compromise language on a drug track and trace system continue to press forward despite the provision's exclusion from the final FDA user fee legislation, as some companies will have to start coming into compliance with a California law by the end of the year if the state measure is not preempted by a federal standard.

June 20, 2012 | Daily News

Lawmakers, brushing aside concerns from a major medical device trade group, included in the final FDA user fee bill a provision requiring FDA to notify Congress 60 days before issuing guidance regulating laboratory developed tests.

June 20, 2012 | Daily News

The device provisions in the final FDA user fee bill are getting mixed reactions from industry and consumer safety advocates with both applauding the timeline for issuance of a Unique Device Identifier rule and addition of devices to FDA's Sentinel initiative, but raising competing concerns about FDA's new flexibility to reclassify devices.

June 18, 2012 | Daily News

Lawmakers excluded from their final FDA user fee agreement a controversial Senate provision that would have reclassified hydrocodone as a schedule II drug and replaced it with language requiring FDA to solicit stakeholder recommendations on how to schedule the pain killer and to conduct a scientific and medical evaluation with the Drug Enforcement Administration.

June 18, 2012 | Daily News

House and Senate lawmakers who negotiated a final FDA user fee bill opted for a drug citizen petition payfor in lieu of a Risk Evaluation and Mitigation Strategy offset preferred by generic drugmakers, who last week accused branded drugmakers of actively lobbying against the REMS language.

June 18, 2012 | Daily News

Efforts to reach a compromise on drug track and trace legislation stalled over the weekend as congressional staff continued efforts to merge FDA user fee bills passed by the House and Senate, with sources saying a drug tracking provision will not be included in the final bill that could be voted on later this week.

June 15, 2012 | Daily News

Senators who sponsored drug shortage legislation urged lawmakers reconciling the two versions of FDA user fee bills to include House and Senate enforcement mechanisms as well as language subjecting biologics to early notification requirements, according to a letter sent Thursday (June 14).

June 15, 2012 | Daily News

Sen. Joe Manchin (D-WV) said he has support from Senate leaders to keep a hydrocodone-reclassification measure in the final FDA user fee bill, but he is also floating a potential compromise in light of growing opposition to the provision.

June 14, 2012 | Daily News

A diverse group of stakeholders appears to be making progress in its press for lawmakers to include biologics in the final user fee bill's drug shortage early notification requirements and to clarify that human plasma protein therapies and their recombinant analogs are subject to the requirement, with a pharmacy stakeholder saying congressional staff has signaled these drugs, along with older medicines, likely will be included in the final bill.

June 14, 2012 | Daily News

Groups opposed to the health reform law are weighing in on FDA user fee payfor mechanisms, saying that both House and Senate options should be included because some savings are dependent on the health reform-created biosimilar pathway and would be wiped out if the Supreme Court shoots down the health law later this month.

June 14, 2012 | Daily News

FDA proposed a drug pedigree system -- expected to start at the lot level but evolve to the unit level -- during a closed-door discussion with user fee negotiators Monday (June 11) aimed at coming up with a compromise drug track and trace proposal for inclusion in the final user fee package, sources said.

June 14, 2012 | Daily News

Groups in support of generic drug access are going public in their push for lawmakers to retain a Senate user fee provision that would prevent brand drug companies from using Risk Evaluation and Mitigation Strategies to impede generics' ability to access innovator drugs to support generic drug applications.

June 12, 2012 | Daily News

A bicamerical investigation into the pharmaceutical gray market has led two Democratic lawmakers to call on House and Senate leaders negotiating a final FDA user fee package to include a national pedigree system and stronger standards for pharmaceutical wholesale distributors, with the lawmakers arguing that an industry-crafted track and trace proposal may not stop unscrupulous companies from exploiting drug shortages to price gouge hospitals and other providers.

June 08, 2012 | Daily News

Stakeholders are pushing lawmakers to include biologics in the final user fee bill's drug shortage early notification requirements and to clarify that human plasma protein therapies and their recombinant analogs are subject to the requirement.

June 06, 2012 | Daily News

Lawmakers working to craft a user fee provision aimed at curbing illegal online pharmacies are now embracing toned-down language that calls for a Government Accountability Office report on the dangers of these websites, following concerns from telemedicine and physician groups that inclusion of a more-aggressive legislative proposal could have interfered with legitimate telehealth services and the doctor/patient relationship.

June 04, 2012 | Daily News

The Advancing Patient Safety Coalition is pushing lawmakers to include the Senate's more stringent language outlining the implementation of the Unique Device Identifier rule when they merge the House and Senate FDA user fee bills.

June 04, 2012 | Daily News

An FDA official said although the agency is not ready to create the kind of track and trace system for medical devices as stakeholders are currently developing for pharmaceuticals, there is a possibility that devices could be required to have serial numbers in the future.

June 01, 2012 | Daily News

Senate lawmakers stripped language authorizing funding for a new FDA nanotechnology program before tacking a provision creating the program onto the upper chamber's version of the user fee bill, a Senate aide said.

May 31, 2012 | Daily News

A provision included in the Senate user fee bill that would allow FDA to more easily reclassify devices is emerging as a possible point of contention as Congress prepares to resolve differences between the user fee bills passed by both chambers, sources said.

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