FDA Policy/General
ZoomRx says it has studied over 30,000 interactions between healthcare providers and sales representatives for over 500 oncology brands to develop three keys to maximize the impact of oncology promotional messaging. The keys are: * keep messages short (10-14 words) and include data; * deliver about four messages and connect
Devices
FDA says Insulet Corp. announced 10/17 a medical device correction for all Omnipod DASH personal diabetes managers distributed globally. An agency notice says the company had received reports from users about device battery issues, including battery swelling and leakage and, in rare cases, extreme overheating resulting in reports of
Drugs
FDA has issued an emergency use authorization (EUA) to Swedish Orphan Biovitrum for its Kineret (anakinra) injection to treat Covid-19 in hospitalized adults with pneumonia requiring supplemental oxygen who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator
FDA Policy/General
Federal Register notice: FDA has canceled an 11/22 Oncologic Drugs Advisory Committee meeting to discuss a GlaxoSmithKline supplemental NDA for Zejula (niraparib) capsules. Panel members were scheduled to discuss the drug’s use for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal
Drugs
FDA has released the form FDA-483 issued following a 10/3-10/14 inspection at the Lupin drug substance and drug product manufacturing facility in Pune, Maharashtra, India. The specific observations were: * aseptic monitoring for fill line, filling and cleaning machine, is not adequate; * failing to make an adequate
Drugs
FDA has released the form FDA-483 with nine observations from a 7/11-8/5 inspection at ImprimisRx NJ, a Ledgewood, NJ, producer of sterile and non-sterile drug products. The inspection observations were: * the ISO 5 classified aseptic processing areas had visibly dirty equipment or surface; * personnel did
FDA Policy/General
Federal Register notice: FDA is announcing a 12/7-8 virtual public meeting entitled “Drug Supply Chain Security Act Implementation and Readiness Efforts for 2023.” Topics to be discussed are stakeholder experiences with implementation and overall readiness regarding implementing enhanced drug distribution security requirements that will go into effect on
Drugs
Washington Legal Foundation (WLF) says the DC Circuit federal court should reject an FDA claim of privilege in denying a Freedom of Information Act request. The case involves Vanda Pharmaceuticals’ suit seeking to compel the agency to produce drug review records associated with the company’s sNDA for Hetlioz (tasimelteon)
Devices
FDA has cleared a RapidAI 510(k) for the latest release of Rapid ICH, an intracranial hemorrhage (ICH) triage and notification product. The company says the latest version improves on its technology that supports physicians’ ability to address intracranial hemorrhagic management more accurately and comprehensively than other available products on
Drugs
FDA’s Pulmonary-Allergy Drugs Advisory Committee 11/9 voted 8 to 5 to recommend against an emergency use authorization for Veru’s investigational prostate cancer drug VERU-111 (sabizabulin) and its use as a treatment for hospitalized adults with moderate to severe Covid-19 who are at high risk
Drugs
An FDA 10/18-10/22/21 inspection at the NatureLab Corp. dietary supplement manufacturing facility in Carrollton, TX, found serious violations of the Federal Food, Drug, and Cosmetic Act and FDA regulations. A just-released 7/12 Warning Letter says the inspection found serious violations of FDA’s current
Drugs
A 3/28-4/6 FDA inspection at Abraxis Bioscience, Phoenix, AZ, identified significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 10/31 Warning Letter says the specific violation was: * failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of
Drugs
FDA has published a guidance, Sameness Evaluations in an ANDA — Active Ingredients, to assist applicants in preparing an ANDA by providing recommendations on demonstrating sameness between the active ingredient in a proposed generic product and its reference-listed drug. The document says FDA will refuse to approve an ANDA if
Drugs
In advance of an 11/9 meeting of the FDA Pulmonary-Allergy Drugs Advisory Committee, FDA medical reviewers are raising several “uncertainties” about a Veru request for an emergency use authorization for its investigational prostate cancer drug VERU-111 (sabizabulin) as a treatment for hospitalized adults with moderate to severe
Drugs
CDER’s Office of New Drugs (OND) has denied an Omeros appeal of a complete response letter (CRL) on its BLA for narsoplimab as a treatment for hematopoietic stem cell transplant-associated thrombotic microangiopathy. In the CRL, according to the company, FDA said it had difficulty in estimating the drug’
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Angel Medical Systems’ AngelMed Guardian System, a device indicated for use in patients who have had prior acute coronary syndrome events and who remain at high risk for recurrent events. The regulatory review period is
Drugs
The Combination Products Coalition (CPC) says its members have recently experienced FDA requesting that combination product manufacturers demonstrate how they have “validated” device user interface specifications in the intended user population. A CPC statement says its member companies are not aware of any agency guidance or recognized consensus standards that
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Kyowa Kirin’s Nourianz (istradefylline), indicated as adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson’s disease experiencing “off” episodes. The regulatory review period is 7,300 days, of which 2,792 days
Devices
Two Wiley Rein attorneys say medical device manufacturers should start now to develop a transition implementation plan and marketing submission to respond to an FDA notice that it will finalize two guidances dealing with the transition of enforcement policies and emergency use authorizations (EUAs) issued as part of the Covid-
Drugs
FDA may be raising the bar for sponsors seeking accelerated approval by requesting that they be “well underway with their Phase 3 confirmatory trial and ideally fully enrolled.” At least, that is the requirement the agency laid out for ADC Therapeutics during a meeting to discuss a potential accelerated approval
Drugs
FDA has approved Regeneron Pharmaceuticals’ PD-1 inhibitor Libtayo (cemiplimab-rwlc) in combination with platinum-based chemotherapy for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with no EGFR, ALK or ROS1 aberrations. “Patients must either have metastatic or locally advanced tumors that
Drugs
FDA Office of Combination Products director Thinh Nguyen says seven priority guidances are in the clearance process and should be published in the first quarter of 2023. Speaking at the Combination Products Summit 2022, Nguyen said the guidances address: * human factors for combination products (final guidance); * essential performance requirement: established