Drugs
FDA says it is refusing entry into the U.S. of fraudulent Covid-19 products or substandard products when it discovers them. The statement came to FDA Webview after our request for comment on a story indicating that the agency has increased its seizure of prescription drugs mailed to American
Devices
Caris Life Sciences says it has submitted PMA applications to FDA for its MI Exome CDx and MI Transcriptome CDx. The company says the two whole transcriptome sequencing (RNA) products “are powerful precision medicine assays that include key companion diagnostic biomarkers with therapy claims, and detect all classes of alterations
Drugs
A 12/10/18-1/28/19 FDA inspection at Professional Compounding Pharmacy (Health Solutions Pharmacy Center), Corvallis, OR, found that the drug products produced by the pharmacy failed to meet conditions for exemption from certain provisions of the Federal Food, Drug, and Cosmetic Act. A just-released 3/31
Devices
FDA has issued a guidance, eCopy Program for Medical Device Submissions, to describe how the agency is implementing the eCopy Program for medical device submissions. The document says the FDA Safety and Innovation Act requires the submission of electronic copies with the issuance of this final guidance. The guidance provides
Devices
In a letter to healthcare providers, FDA says it recognizes that the need for personal protective equipment (PPE) such as surgical masks, surgical and isolation gowns, and surgical scrubs may outpace the supply available during the Covid-19 outbreak. A separate letter refers specifically to medical gloves. The gown and
FDA Policy/General
FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below: Health Solutions Pharmacy Center, Corvallis, OR (3/31): FDA inspected the firm in January and cited serious deficiencies in its practices for
Drugs
FDA has granted Takeda Pharmaceutical a breakthrough therapy designation for its investigational drug mobocertinib (TAK-788) for treating patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy. Mobocertinib is a
Drugs
FDA says it is aware that the Covid-19 pandemic may affect the conduct of bioequivalence studies intended for submission in ANDAs. “For example,” an online statement says, “challenges may arise from quarantines, site closures, travel limitations, interruptions to the supply chain for the proposed generic product or the reference-
Drugs
FDA says that over 1,500 additional manufacturers have registered with the agency to produce hand sanitizer. An agency statement says it also is addressing safety concerns related to products being sold that are not in line with agency policy and others being marketed with unproven claims. The statement says
Drugs
FDA has sent Prefense LLC (Muscatine, IA) a Warning Letter for marketing unapproved hand sanitizers for preventing Covid-19. The agency objected to numerous claims on the company’s Web site and social media platforms, such as “Sanitize your hands with Prefense nonalcoholic Hand & Skin sanitizer that can protect
FDA Policy/General
Federal Register notice: FDA has submitted to OMB a new information collection entitled “Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program.” FDA is required to establish a pilot program under which testing laboratories may be accredited to assess the conformance of a device within certain FDA-recognized standards. Determinations by
Devices
The Massachusetts U.S. Attorney’s Office has announced that physician Jeffrey R. Carlson (Newport News, VA) has agreed to pay $1.75 million to resolve allegations that he accepted kickbacks from SpineFrontier, a Massachusetts-based medical device manufacturer. In March, the government filed a False Claims Act complaint against
Devices
FDA told a Congressional briefing earlier this month that it is considering tougher requirements on Covid-10 serology (antibody) tests that are currently coming on the market without normal vetting or review under the agency’s emergency use authorization (EUA) pathway. The 4/17 briefing before House Oversight Committee staff
Drugs
FDA has approved a Neurocrine Biosciences NDA for Ongentys (opicapone) 25 mg and 50 mg capsules as an add-on treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing “off” episodes. As the disease progresses, patients taking levodopa/carbidopa may begin to experience “off” time between treatment doses
Devices
FDA has issued a letter to health care providers that updates risk information for gastric balloon devices used for weight loss. Results from two FDA-required post-approval studies provide updated information on two specific risks — device over-inflation or spontaneous hyperinflation, and sudden pancreas inflammation (acute pancreatitis). “FDA wants
Biologics
CytoDyn has submitted clinical and chemistry, manufacturing and controls portions of a BLA for leronlimab as a combination therapy with antiretroviral therapy in treatment experienced HIV patients. FDA previously granted both a fast track designation for leronlimab and a rolling review for its BLA. Leronlimab is an investigational humanized IgG4
FDA Policy/General
Unilife Corp. and Amgen have entered into a strategic collaboration for injectable drug delivery systems. According to the companies, Unilife has granted Amgen exclusive rights to Unilife’s wearable injectors within select drug classes for use with certain Amgen assets, while preserving rights previously granted to other Unilife customers. Also,
FDA Policy/General
Federal Register notice: FDA announces it is contemplating a grant of an exclusive patent license to Sciogen (San Jose, CA) for two patents: 1. U.S. Patent No. 9,163,068 issued 10/20/2015 and entitled “Influenza Virus Recombinant Proteins” 2. U.S. Patent No. 9,896,484 issued
Devices
FDA has granted a Bayer request for a variance from some medical device reporting requirements, specifically reportable adverse events Bayer is or becomes aware of from social media information received in relation to ongoing litigation regarding its controversial Essure contraceptive. The agency issued a letter to Bayer outlining conditions for
FDA Policy/General
Federal Register notice: FDA has reopened for 60 days the comment period for a 1/3 Federal Register notice seeking input from interested stakeholders, including racial and ethnic minority, underrepresented, and underserved populations on the Office of Minority Health and Health Equity Strategic Priorities. To view the notice, click here.
Drugs
Janssen Pharmaceutical has submitted two supplemental BLAs for Simponi Aria (golimumab) for treating polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis in patients two years of age and older in combination with methotrexate. Juvenile Idiopathic Arthritis (JIA) is a disorder group characterized by arthritis persisting for at least six weeks
Devices
FDA has asked a Massachusetts federal court to lift portions of a consent decree affecting Royal Philips and its Emergency Care and Resuscitation business to allow the company to resume manufacturing and shipping external defibrillators for the U.S. market. The 11/2017-ordered decree (see earlier story) suspended external