Fda Approval

Fitzpatrick Stands Up for Medical Device Protection (Michael G Fitzpatrick)

Edit Public Technologies 01 Dec 2016

It provides funding for cancer research at the NIH, grants money to states to fight opioid abuse, helps individuals and families in mental health crisis and improves the FDA's review of life-saving drugs for patients,' said Fitzpatrick ... Furthermore, the FDA acknowledges that these problems are widespread ... This law would remove the blanket liability protections given to medical devices approved under the FDA's Premarket Approval (PMA)....

CRAMER: 21st Century Cures Act a Game Changer for Medical Research and Innovation (Kevin Cramer)

Edit Public Technologies 01 Dec 2016

(Section 2036) Expedites the development and review of drugs for subgroups of rare disease patients by authorizing FDA to rely on data submitted in previously approved applications involving similar gene targeting technology ... (Section 3023) Authorizes FDA to rely upon qualified data summaries to support the approval of supplemental applications ... (Sections 3052-3059) Exempts certain software and personal health apps from FDA regulation....

Congressman Chris Collins Helps Pass Landmark Medical Innovation Legislation (Chris Collins)

Edit Public Technologies 01 Dec 2016

These changes to the way the FDA approves clinical trial designs will help unleash new, groundbreaking therapies by allowing researchers to efficiently change their trials to meet the individual responses of their participants ... This will help ensure that our best and brightest scientists will remain with the FDA to review and approve drug applications, and get cures to patients more quickly....

Rep. Kelly Supports 21st Century Cures Act (Mike Kelly)

Edit Public Technologies 01 Dec 2016

(Section 2036) Expedites the development and review of drugs for subgroups of rare disease patients by authorizing FDA to rely on data submitted in previously approved applications involving similar gene targeting technology ... (Section 3023) Authorizes FDA to rely upon qualified data summaries to support the approval of supplemental applications ... Brings the FDA into the 21st century....

Opioid Funding, Mental Health Reform, and Lyme Disease Research Legislation Sails Through House (Bill Shuster)

Edit Public Technologies 01 Dec 2016

This landmark legislation reforms the way the Food and Drug Administration (FDA) approves new drugs and devices, while increasing funding for medical research at the National Institute of Health (NIH) ... In order to reduce costs and speed up approval times the Cures Act will make it easier for the NIH, FDA, and other research arms of the government to ......

Premier Inc. Statement on House Passage of 21st Century Cures Act (Premier Inc)

Edit Public Technologies 01 Dec 2016

strongly supports the 21st Century Cures Act, in particular the provisions for EHR interoperability, socio-economic factors in the hospital readmissions program and a speedier FDA approval process ... In addition, we support provisions that will enhance the FDA approval process to advance the entry of new drugs ......

Pallone Leads Democratic Efforts to Pass 21st Century Cures through House (Frank Pallone Jr)

Edit Public Technologies 01 Dec 2016

$500 million to the FDA over 10 years to foster innovation and to help implement numerous provisions in the bill intended to improve FDA's medical product review in order to expedite patient access to important drugs and medical devices ... Though most of the harmful language was taken out, I remain troubled that this bill creates a new designation process under FDA's accelerated approval pathway....

FDA Grants Priority Review to Supplemental Biologics License Application (sBLA) for Merck’s KEYTRUDA® (pembrolizumab) in Relapsed or Refractory Classical Hodgkin Lymphoma (Merck & Co Inc)

Edit Public Technologies 01 Dec 2016

The sBLA will be reviewed under the FDA's Accelerated Approval program ... KEYTRUDA is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression [tumor proportion score (TPS) ≥50%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations....

21st Century Cures Act will distort the meaning of ‘FDA approved’

Edit Raw Story 01 Dec 2016

The term “FDA approved” means a lot to those of us working in health care and the patients we treat. But if the 21st Century Cures Act becomes law – the House of Representatives approved it Wednesday and the Senate will vote on it next week – this mark of trustworthy stewardship will become a […]> ... ....

FDA Grants Priority Review to Supplemental Biologics License Application (sBLA) for Merck’s KEYTRUDA® (pembrolizumab) in ...

Edit Stockhouse 01 Dec 2016

The sBLA will be reviewed under the FDA’s Accelerated Approval program ... KEYTRUDA is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression [tumor proportion score (TPS) ≥50%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations....

Rep. Huffman Supports 21st Century Cures Act (Jared Huffman)

Edit Public Technologies 01 Dec 2016

While Congressman Huffman supported the legislation, he cautioned that Congress must provide the necessary resources that this legislation authorizes, including providing the funding needed for the FDA to implement new responsibilities under the bill ... No compromise is ever perfect, however, which is why we will now need to ensure full funding for the FDA and others to carry out the important public health initiatives in the bill.'....

Schakowsky Statement in Opposition to the 21st Century Cures Bill (Jan Schakowsky)

Edit Public Technologies 01 Dec 2016

One of the most troubling aspects of this legislation is that it would loosen the standards under which the Food and Drug Administration (FDA) prevents dangerous drugs and medical devices from reaching consumers ... We need to make the FDA's standards stronger--not weaker ... These lethal devices came to the market after the FDA 'accelerated' their approval, and did so without substantial clinical data....

House Approves 21st Century Cures ActCongressman Smith supports ‘once-in-a-generation’ opportunity to bring treatments to patients in need (Chris Smith)

Edit Public Technologies 01 Dec 2016

Currently, of the estimated 10,000 known diseases, only 500 have effective treatments or cures and an estimated 95 percent of rare disease have no FDA approved treatment ... Create 'Innovation Accounts' to provide for dedicated funding for NIH and FDA Cures-related activities; ... Incentivize the development of drugs for pediatric diseases and reform the FDA approval process for new and innovative medical devices;....

Food and Drug Administration

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