Experts: PASTEUR, VALID Could Help Spur Bacterial Diagnostics For AMR

Diagnostic tests are essential to combating antimicrobial resistance (AMR), but developers face myriad challenges getting their tests through FDA, and the ones that do make it to market have to grapple with reimbursement issues, a panel of former FDA officials, academics and industry experts said during a Duke-Margolis webinar last week. The experts, who called for increasing funding for bacterial diagnostics, noted that two bills being considered by Congress -- the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act...
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InsideHealthPolicy.com
FDA Issue: 
FDA Week - 09/23/2022
FDA Volume: 
Vol. 28, No. 38
CMS Issue: 
Inside CMS - 09/29/2022
CMS Volume: 
Vol. 25, No. 39
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FDA Details CPA Process For Generic Makers Seeking Brand Drug Samples

FDA on Wednesday (Sept. 21) published a draft guidance that explains how drug makers can obtain a so-called covered product authorization to access product samples of reference drugs that are subject to a risk mitigation strategy. The CPA pathway was created under the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act that was enacted in December 2019. CREATES allows makers of generic and 505(b)(2) drugs and biosimilars to sue brand companies that refuse to provide product samples that...
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Site Name: 
InsideHealthPolicy.com
FDA Issue: 
FDA Week - 09/23/2022
FDA Volume: 
Vol. 28, No. 38
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