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User Fees

July 19, 2012 | Daily News

FDA is continuing to move forward in developing a national post-market medical device surveillance system by seeking outside help to craft a roadmap for development and maintenance of device registries, with the move coming as the agency also works to implement the Unique Device Identifier system to track devices.

July 13, 2012 | Daily News

Key FDA reforms -- such as tools to prevent drug shortages and antibiotic exclusivity incentives -- are immediately available following the July 9 enactment of the FDA Safety and Innovation Act mans, but the agency must also develop several policies in the coming years on a slew of hot-button issues ranging from social media regulation to antibiotic development.

July 12, 2012 | Daily News

Lawmakers and congressional staff are regenerating efforts to establish a national drug track and trace system and started meeting to discuss the topic this week, including discussions with FDA, several sources said.

July 12, 2012 | Daily News

Stakeholders watching the reauthorization of the Pandemic and All-Hazards Preparedness Act expressed concern this week that the bipartisan bill reauthorizing HHS medical countermeasure programs could become a Christmas tree for other provisions that failed to make it into the final FDA user fee bill, including a drug track and trace measure.

July 09, 2012 | Daily News

FDA is laying the groundwork to track its revamped review program for new molecular entity new drug applications and biologics license applications, a program outlined in the industry-agency negotiated user fee pact that both parties hope will increase first cycle reviews.

July 09, 2012 | Daily News

Lawmakers are continuing to push legislation to address the drug shortage problem that did not make it into FDA Safety and Innovation Act, but sources said outstanding proposals to curb the gray market and change reimbursement for some medications are not likely to gain much traction in the coming months.

July 05, 2012 | Daily News

Once pending user fee legislation is signed into law FDA will need to speed up by one year its proposed timeline for applying the Unique Device Identifier system to some implantable devices to follow the new law's requirements, agency device center officials said Tuesday (July 3) as they rolled out a long-awaited UDI proposed rule.

July 03, 2012 | Daily News

A citizen petition payfor in the recently passed FDA Safety and Innovation Act will likely do little to cut down on the number of citizen petitions filed by brand pharmaceutical companies targeting generic drugs, according to a law professor who recently published a study that found legislation enacted in 2007 to curb these petitions has not been successful.

June 27, 2012 | Daily News

BOSTON -- FDA and drug company officials said they are optimistic the agency will meet drug performance goals this time around despite the user fee bill's significant changes to the review process and the slew of reforms attached.

June 27, 2012 | Daily News

The FDA Safety and Innovation Act cleared Congress with a 92 to 4 Senate vote Tuesday (June 26) after Sen. Richard Burr (R-NC) spoke for hours on the Senate floor pointing out shortfalls of the bill, which he said was unnecessarily rushed through Congress ahead of the Supreme Court ruling on health reform and, given extra time, could have resolved several issues, including the creation of a federal track and trace system.

June 26, 2012 | Daily News

The authors of a new study that reveals metal-on-metal hip implant manufacturers initiated FDA-mandated post-market studies for only 24 of 104 products last year are hopeful that device reforms moving through Congress will avert such lags in the future, but also urge FDA to go a step further and pursue a comprehensive national device postmarket safety registry.

June 25, 2012 | Daily News

The final user fee bill on the Senate floor Monday (June 25) gives FDA discretion to include biologics in the legislation's drug shortage early notification requirements -- a move applauded by a coalition of pharmacists, providers, hospitals and patient groups that was upset the original House version of the bill didn't address the issue.

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).

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