Devices
FDA has cleared an Applied BioCode 510(k) for its BioCode Respiratory Pathogen Panel (RPP) for use on the BioCode MDx-3000 System. The RPP tests nasopharyngeal swabs for of the most common viruses and bacteria, including Influenza A and subtypes H1, H1N1 2009pdm and H3, Influenza B, respiratory syncytial
FDA Policy/General
Patient Engagement Panel Renewed for 2 Years Federal Register notice: FDA renews for two years the charter for its Patient Engagement Advisory Committee. 01/06/2020 Pharmaceutical Science Panel Charter Renewal Federal Register notice: FDA has renewed for another two years the charter for its Pharmaceutical Science and Clinical Pharmacology
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for its guidance on “Special Protocol Assessment” (OMB Control Number 0910-0470). The guidance describes agency procedures to evaluate issues related to the adequacy (e.g., design, conduct, analysis) of certain proposed studies. To view the notice, click
Devices
Cook Medical has recalled (Class 1) its CrossCath Support Catheters due to a manufacturing error which may cause the marker bands to dislodge. A recall notice says that the company has identified that an error occurred during manufacturing which may cause the radiopaque marker bands to be too loose or
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision for “Imports and Electronic Import Entries” (OMB Control Number 0910-0046). FDA’s regulations prescribe the required data elements that respondents must submit when importing, or offering for import, an FDA-regulated article into the U.S. The
Devices
Smiths Medical ASD has recalled its Medfusion 4000 Syringe Pumps due to malfunctioning alarms and potential therapy interruption. The company has become aware of a software issue in the most recently updated device firmware, version 1.7.0, that could potentially cause the low battery alarms to stop working, a
Devices
Chembio Diagnostics says it expects FDA approval in two months on its PMA for the DPP HIV-Syphilis System. The single-use, 15-minute screening test simultaneously detects antibodies to HIV Types 1 and 2 and the bacteria that causes syphilis, Treponema pallidum. It uses a 10 microliter sample of
Devices
Several stakeholders are asking FDA to clarify its revised draft guidance on clinical and patient decision support software (CDS). AdvaMed says it is encouraged that the guidance uses a risk-based framework as called for by the 21st Century Cures Act and welcomes the use of several items from the
Biologics
FDA has accepted for review an Immunomedics resubmitted BLA seeking accelerated approval for sacituzumab govitecan, indicated for treating patients with metastatic triple-negative breast cancer who have received at least two prior therapies for metastatic disease. In 01/2019, FDA issued a complete response letter on the original submission. “The
Drugs
Several stakeholders are asking FDA to clarify elements in its draft guidance on methods to identify what is important to patients that is part of the agency’s series of guidances on patient-focused drug development. The National Organization for Rare Disorders says it appreciates that the emphasis of the
Drugs
Authors from FDA and several other organizations and academic centers analyze progress and challenges in developing new therapies for rare diseases. A Nature drug discovery review article says that addressing the translational gap is a multifaceted challenge for which a key aspect is the selection of the optimal therapeutic modality
Drugs
Kaiser Permanente says that expanding the scope of circumstances when postmarketing requirements (PMRs) can apply could increase available scientific evidence about drugs, which will support evidence-based treatment decisions and improve the quality of care. The company strongly encourages FDA “to apply and enforce meaningful PMRs to assess serious risks
Drugs
FDA has again issued Correvio Pharma a complete response letter on its NDA for Brinavess (vernakalant IV), an anti-arrhythmic drug for converting atrial fibrillation, due to safety concerns. The agency letter provided recommendations needed for resubmission, according to the company. “FDA stated that while the submitted data provides substantial
Drugs
Washington Legal Foundation (WLF) says the HHS Office of Inspector General (OIG) should reverse its decision to exclude drug and medical device manufacturers from the protection of proposed anti-kickback statute safe harbors. In a 12/31/19 comment, WLF praised the OIG’s removal of regulatory barriers to care
Drugs
FDA has approved an Eisai NDA for Dayvigo (lemborexant) 5 mg and 10 mg for treating adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. The approval was based on data from two pivotal Phase 3 studies, which evaluated the drug versus placebo for up
Drugs
FDA says that dropping the exclusion of chemically synthesized polypeptides from the March opening of most protein products that were approved as drugs, including all currently marketed insulins, to biosimilar and interchangeable competition “will help patients because it provides the potential for chemically synthesized follow-on insulins and other protein
Drugs
FDA has given accelerated approval to Astellas Pharma’s Padcev (enfortumab vedotin-ejfv), a Nectin-4 directed antibody and microtubule inhibitor conjugate, for treating adults with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 or programmed death ligand-1 inhibitor and platinum-containing
Drugs
FDA says it will use information in a National Academies of Science, Engineering, and Medicine report it contracted on framing opioid prescribing guidelines for acute pain as it implements the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act. That act requires FDA to
Drugs
Rep. Jan Schakowsky (D-IL) and Sen. Elizabeth Warren (D-MA) have reintroduced their Affordable Drug Manufacturing Act (H.R. 5501), described as an “ambitious proposal to address the skyrocketing price of prescription drugs.” A statement issued by Schakowsky (includes links to bill text and summary) says the measure would
Drugs
President Donald Trump and HHS are proposing a rule that, if finalized, would allow the importation of certain prescription drugs from Canada. The administration also announced a draft guidance with procedures drug manufacturers could follow to facilitate importation of prescription drugs, including biologics, that are FDA-approved, manufactured abroad, authorized
Drugs
FDA says that serious breathing difficulties may occur in patients using gabapentin (Pfizer's Neurontin, Assertio’s Gralise, Arbor’s Horizant) or pregabalin (Pfizer’s Lyrica and Lyrica CR) who have respiratory risk factors. In a drug safety communication, the agency said its evaluation showed that the use of
Drugs
Attorney James Beck (Reed Smith) says that with its announcement of the availability of CURE ID, an Internet-based repository of physician information on off-label success stories, FDA appears to be getting into the off-label promotion business itself. Writing in the Drug and Device Law blog, Beck says