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    Woodcock, Industry Groups Tell House E&C Committee PDUFA Reauthorization Delays Could be Dire

    Leaders from the biopharmaceutical industry lobby and a patient advocacy group on Wednesday urged members of the House Energy and Commerce Committee to reauthorize the sixth iteration of the Prescription Drug User Fee Act ( PDUFA VI). And, in her second straight day of testimony on user fees before Congress, Janet Woodcock, director of the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) detailed how the agency's ability to...
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    FDA Considers Creating New 'Office of Patient Affairs'

    As part of efforts to better capture patients' perspectives, the US Food and Drug Administration (FDA) on Monday said it is considering establishing an "Office of Patient Affairs," to be tasked with supporting and coordinating patient engagement across the agency. The move to create the office would be part of the agency’s efforts to offer “a single, central entry point to the Agency for the patient community,” as well as “triage and navigation services for inbound inqu...
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    FDA Drafts List of Class II Devices to be Exempt From Premarket Notification

    The US Food and Drug Administration (FDA) began implementing the recently passed 21st Century Cures Act on Monday by publishing a draft list of class II devices that will be exempt from premarket notification requirements, or 510(k)s. FDA said in a statement that it “believes that the devices identified in the Federal Register are sufficiently well understood and do not present risks that require premarket notification review to provide a reasonable assurance of safe...
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    Law Firm Challenges FDA on Combination Product Appeals

    Healthcare law firm Epstein Becker & Green (EBG) is calling on the US Food and Drug Administration (FDA) to improve how it handles challenges to its designation decisions for combination products. In a citizen petition sent to FDA last week, the firm says that lengthy delays for such appeals negatively affects both product sponsors and patients by delaying the launch of new combination products. Background Combination products, or products that combine two or more diff...
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    GAO: Drugmakers Want More Clarity on Antibiotic Incentives

    Despite some improvements, drugmakers say the US Food and Drug Administration (FDA) has not fully clarified its expectations for developing new antibiotic drugs or detailed how to access new incentives, according to a new report by the Government Accountability Office (GAO). Specifically, GAO says that FDA has issued 14 updated or new guidances focused on antibiotics since the Generating Antibiotic Incentives Now (GAIN) Act was passed as part of the Food and Drug Admi...
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    House Bill Would Incentivize Drugmakers to 'Repurpose' Drugs for Rare Diseases

    Rep. Gus Bilirakis (R-FL) on Monday reintroduced a bill that would grant drugmakers an additional six months exclusivity for repurposing already-approved drugs to treat rare diseases. The bill, known as the Orphan Product Extensions Now Accelerating Cures and Treatments (OPEN) Act , was initially included in the 21st Century Cures Act , but was removed before it was signed into law last year. The additional exclusivity for new orphan indications under the OPEN Act w...
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    FDA Discusses Upcoming Proposed Rule on One-Page Patient Medication Information

    Officials from the US Food and Drug Administration (FDA) gathered on Thursday at DIA's advertising and promotion conference in Washington, DC, to discuss recent research, guidance for industry and enforcement action on pharmaceutical and medical device advertising and promotion. The new administration’s impact on FDA was not discussed, though some officials discussed how FDA is moving forward with initiatives begun under President Barack Obama’s administration. Elizabe...
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    21st Century Cures Act Deadlines Approach in March and June

    The massive 21st Century Cures Act, rushed to passage in the waning days of President Barack Obama’s presidency, features a whole host of provisions that will take years for the US Food and Drug Administration (FDA) and National Institutes of Health (NIH) to digest and implement, but it also includes several provisions that must be addressed by 13 March. Among those provisions of the law that must be acted upon within 90 days of the law’s enactment (or by 13 March) inc...
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    Sen. Grassley Opens Inquiry Into Orphan Drug Act

    Sen. Charles Grassley (R-IA) on Friday confirmed to Focus that he is gathering more information and discussing with his staff and interested parties a possible inquiry into the Orphan Drug Act ’s abuses leading to high drug prices. “Based on the reporting from Kaiser Health News [KHN] about how the orphan drug provisions appear to be stretched beyond their original intent, and the strong consumer concern about high drug prices, I'm interested in learning whether...
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    FDA Approves New Labeling for Essure, Closes Trade Complaint Against Bayer

    The US Food and Drug Administration (FDA) on Tuesday said it has approved new labeling for Bayer's permanent birth control device Essure, in line with the agency's recently finalized labeling guidance . With the approval of the new labeling, FDA said it has also closed its investigation of a trade complaint , initially filed as a citizen petition , against Bayer concerning the device. FDA spokesperson Angela Stark told Focus the investigation included a review of E...
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    Lead MDUFA Negotiator Details Changes in MDUFA IV Financing

    The US Food and Drug Administration's (FDA) top negotiator for the fourth iteration of the Medical Device User Fee Act (MDUFA IV) presented changes to the funding mechanisms of the program at a public meeting at FDA's White Oak Campus on Wednesday. Last week, FDA released its draft recommendations for changes to its user fee program for medical devices which would allow the agency to collect roughly $999.5 million— an increase of $320 million over the previous five-yea...
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    FDA Finalizes Guidance on Boxed Warning, Patient Decision Checklist for Essure Devices

    The US Food and Drug Administration (FDA) on Friday finalized its guidance requiring a boxed warning and patient decision checklist for Bayer's permanent implantable birth control device Essure. While the final guidance retains most of the recommendations made in the draft version, both the language of the boxed warning and patient decision checklist have been updated. However, these changes are unlikely to settle concerns from patients who say they have been harmed by ...