• Regulatory NewsRegulatory News

    Senate Bill Seeks to Create Standards Body for Regenerative Medicine

    Sen. Tammy Baldwin (D-WI) introduced a bill on Tuesday to promote the development of regulatory science and standards for regenerative medicine and advanced therapies. The bill, known as the Advancing Standards in Regenerative Medicine Act , would require the US Food and Drug Administration (FDA) to oversee the creation of a "Standards Coordinating Body" for regenerative medicine. Regenerative medicine and advanced therapies belong to a growing field of medicine that i...
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    Senate Investigation Blames Superbug Outbreaks on Poor FDA Oversight

    A Senate report released Wednesday finds that the US Food and Drug Administration's (FDA) post-market surveillance system for tracking medical devices is ineffective. The report found systemic issues related to device oversight and reporting, which contributed to at least 25 superbug outbreaks linked to closed-channel duodenoscopes that infected some 250 patients in the US and Europe between 2012 and 2015. Duodenoscopes made headlines in early 2015 after Carbapenem-resi...
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    Senators Propose New Exclusivity Voucher, Priority Review Voucher Programs

    Senators on both sides of the aisle are trying to incentivize the development of new drugs for newborn babies and medical countermeasures via a new exclusivity voucher and a priority review voucher system that are similar to the voucher programs already linked to tropical and rare pediatric disease treatments. Neonatal Exclusivity Voucher Last month, Sen. Robert Casey (D-PA) introduced a bill, known as Promoting Life-Saving New Therapies for Neonates Act of 201...
  • Senators to Hamburg: Ongoing Shortages of Pediatric Drugs Call for Regulatory Response

    One of the biggest regulatory news stories of 2011 revolved around the issue of drug shortages, the outcome of a multitude of unfortunate circumstances that had the effect of causing many drugs-and in particular sterile injectables, the likes of which are often used to combat cancer-to be either partially or fully unavailable to patients. But a curious thing has happened in the last few months: Media attention about drug shortages is itself in short supply. Senators: Ge...
  • In Wake of Meningitis Outbreak, Senator Calls for New FDA Authority to Regulate

    In the wake of a widespread outbreak of meningitis, at least one US senator is calling for new authority to be given to the US Food and Drug Administration (FDA) to make its authority to oversee compounding pharmacies clearer and more robust. In remarks reported by CBS New York , Sen. Richard Blumenthal (D-CT) said he remained concerned that FDA did not have sufficient authority to investigate compounders. "We need to bolster the authority of the FDA and make sure ...
  • Prominent Senator Slams FDA over Surveillance Program

    It's safe to say that Senator Charles Grassley (R-IA) is less than enamored with the US Food and Drug Administration (FDA) as of late. The Senator, who has been investigating the agency's alleged treatment of nine whistleblowers and a related surveillance program, took to the Senate floor on Tuesday, 17 July to lambaste the agency's actions . FDA has "forgotten that it works for the American public," said Grassley at the top of his remarks. "This is an agency that has ...
  • Senator: Regulators and Medical Device Manufacturers Must Find Common Ground

    Minnesota Senator Al Franken (D-MN) told media present at the Design of Medical Devices Conference he doesn't believe there needs be a choice between having medical devices be proven safe or having those devices be brought to market quickly, reports The Star Tribune . "To some degree, there is a false choice there," said Franken, a member of the Senate Health, Education, Labor and Pensions Committee which oversees the US Food and Drug Administration. The way forward, e...
  • Bill Would Address Medical Device Safety By Giving FDA Additional Authority

    A new bill introduced in the Senate would address medical device safety by giving the US Food and Drug Administration (FDA) additional authority to conduct postmarketing surveillance. "Strong post-marketing surveillance of medical devices will ensure that those that are defective or cause harm can be quickly identified, patients and their physicians can be notified, and dangerous products can be removed from the market," said Senator Jeff Merkley, the bill's chief sponso...