Drugs
A 2/24-3/17 FDA inspection at Cosmax USA, Ridgefield Park, NJ, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 10/15 Warning Letter says specific violations were: * failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of
Devices
A 10/19 CDRH Webinar listening session explained the “roadmap” governing the new Digital Health Center of Excellence (DHCoE) and heard comments from stakeholders. DHCoE director Bakul Patel said the organization’s goal is to empower digital health stakeholders to advance healthcare. “We believe digital health has the potential to
Devices
Medtronic has begun a Class 1 recall of its Rashkind Balloon Septostomy Catheters because of device quality issues that may lead to the device breaking, separating or failing during use. If this occurs, use of the affected product may cause serious injuries, such as damage to blood vessels and death,
Drugs
FDA says its review of a Web site maintained by Immusist LLC, Gig Harbor, WA, determined that the company is selling two unapproved new drugs — Immusist Original and Immusist Natural — intended for use in the cure, mitigation, treatment, or prevention of disease. A 10/16 Warning Letter lists Web site
FDA Policy/General
In an online story, Politico reports that many senior officials within FDA are expressing alarm about a 10/21 Executive Order issued by President Trump that would make it easier to fire federal employees who have Civil Service protection. “There’s a legitimately palpable fear this could be wielded as
Biologics
The CBER Office of Compliance and Biologics Quality says the Young Foundational Health Center, Largo, FL, is using a Web site, Facebook, and YouTube to market a cellular product administered intravenously for various diseases or conditions. A 10/30 Warning Letter says the product is sometimes referred to in promotional
Devices
FDA says clinical laboratory staff and healthcare providers should be aware that false positive results can occur with antigen tests, including when users do not follow the instructions for use of antigen tests for the rapid detection of SATS-CoV-2. An agency statement says laboratories “should expect some false
Drugs
FDA has approved updated prescribing information for Emmaus Life Sciences’ Endari (L-glutamine oral powder) to better inform healthcare professionals and sickle cell disease patients. The updated label includes a statement that the clinical benefit of Endari was observed irrespective of hydroxyurea usage and a new step-by-step instructions
FDA Policy/General
UC Hastings School of Law professor Dorit Reiss says that while FDA was not designed to be independent, it is perhaps time to discuss whether it should be. Writing in a StatNews opinion piece, Reiss cites the concerns of public health experts and lay observers that FDA will prematurely approve
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery,” (OMB Control Number 0910-0697). The collection applies to feedback that is intended to provide insights into customer or stakeholder perceptions, experiences and expectations, provide
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile” (OMB Control Number 0910-0614). FDA says that it may be appropriate for certain medical products that are in the stockpile to be
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Cosmax USA, Ridgefield Park, NJ (10/15): FDA inspected the firm in February and found significant GMP violations for finished pharmaceuticals. For example, Cosmax failed to thoroughly investigate any
Drugs
FDA has granted Salix Pharmaceuticals an orphan drug designation for rifaximin and its use in treating sickle cell disease. Early data suggest that rifaximin may reduce vaso-occlusive crisis in patients with sickle cell disease, the company says. Salix says it is finalizing Phase 2 trial protocols to further evaluate
Drugs
In April, the White House reportedly ordered the National Strategic Stockpile to distribute 23 million hydroxychloroquine tablets from its inventory to a dozen states for treating Covid-19 patients. The drug shipments were sent to several commercial distributors with orders to send them directly to hospitals and retail pharmacies in
Drugs
Significant quality and laboratory control issues are cited in a just-posted Form FDA-483 issued to Eli Lilly after an August reinspection at its Imclone manufacturing facility in Branchburg, NJ. The GMP problems could pose a hurdle for a promising Covid-19 drug that will be made there. Last
Drugs
An FDA/industry Prescription Drug User Fee Act reauthorization subgroup met recently to discuss the agency’s plans on risk evaluation and mitigation strategies (REMS) assessment modernization under the next user fee program that starts in late 2022, according to a summary of the meeting. FDA says its REMS proposals
Drugs
FDA commissioner Stephen Hahn says that the agency, the U.S. Customs and Border Protection (CBP)and the U.S. Immigration and Customs Enforcement have signed a memorandum of understanding (MOU) to stop harmful products that pose a threat to public health and attempt to enter the U.S. through
Devices
FDA has approved Boston Scientific’s Ranger Drug-Coated Balloon for treating patients with peripheral artery disease (PAD) in the superficial femoral artery (SFA) and proximal popliteal artery (PPA). The company says the device was designed with a “low therapeutic drug dose and proprietary coating which efficiently transfers the drug
Drugs
Janssen Pharmaceutical has submitted a supplemental NDA for paliperidone palmitate 6-month (PP6M) for treating adults diagnosed with schizophrenia. If approved, PP6M will be the first and only long-acting injectable schizophrenia medication with a twice-yearly dosing regimen, Janssen says. FDA approved a Janssen NDA in 2015 for Invega
FDA Policy/General
AstraZeneca has sold the U.S. rights to its anesthetic portfolio to Aspen Global for $555 million. The portfolio includes Diprivan, EMLA, Xylocaine/Xylocard/Xyloproct, Marcaine, Naropin, Carbocaine and Citanest, according to the companies. The deal comes about 14 months after Aspen acquired the non-U.S. rights to the
FDA Policy/General
DEVICES FDA has cleared a Butterfly Network 510(k) for what the sponsor describes as the world’s first “ultrasound-on-a-chip” based imaging system, the Butterfly iQ for the iPhone. The clearance covers 13 clinical applications, the “broadest ever for a single ultrasound transducer,” the company says. “By
FDA Policy/General
Comment Period Reopened on Metered Dose Inhaler Guide Federal Register notice: FDA reopens the comment period for its “Metered Dose Inhaler and Dry Powder Inhaler Drug Products — Quality Considerations; Draft Guidance for Industry.” 10/30/2020 Comment Period Extended on E-Data Files guide Federal Register notice: FDA extends the