Drugs
Spectrum Laboratory Products has recalled three lots of epinephrine (L-adrenaline) USP, a bulk active pharmaceutical ingredient used to manufacture or compound prescription products. The recall is based on customer complaints about product discoloration. “The use of a finished dose product manufactured or compounded with this recalled product could result
Devices
Two artificial intelligence (AI) experts writing in a Stat News opinion column say there are four areas in which bias can enter an algorithm used in medicine that should be addressed by FDA. Gesund CEO Enes Hosgor and radiologist Oguz Akin say the four areas that can skew the performance
Devices
FDA says it is partnering with Health Canada on an eSTAR pilot to test the use of a single eSTAR submitted to both agencies. An FDA notice describes eSTAR as an interactive PDF form that guides applicants through the process of preparing a comprehensive medical device submission. It says eSTAR
Drugs
The Association for Accessible Medicines (AAM) says it appreciates FDA issuing a draft guidance with recommendations on demonstrating sameness between the active ingredient in a proposed generic drug product and its reference-listed drug. “The draft guidance effectively consolidates various policies we’ve seen in other documents or heard from
Devices
AdvaMed is making several recommendations to FDA in response to the agency’s public workshop on the appropriate use of consensus standards. The advocacy organization recommends that FDA: * issue a clear policy statement of a default three-year transition period for standards; * establish an e-mail list serve to notify
Drugs
While drug and biologic approval totals were precipitously lower last year (see CDER Dismisses 26% Drop in 2022 Drug Approvals), the Center’s “first cycle approval” rate for NDAs/BLAs approved in 2022 also fell from 86% in 2021 to 76% (28 of the 37 novel approvals) in 2022, according
Biologics
FDA has extended by three months a Krystal Biotech BLA for B-Vec (beremagene geperpavec), a gene therapy indicated for treating patients with dystrophic epidermolysis bullosa (DEB), after it submitted manufacturing data pursuant to an agency information request. The topical gene therapy is designed to treat DEB at the molecular
Drugs
FDA has accepted for priority review an Otsuka Pharmaceutical and H. Lundbeck supplemental NDA for brexpiprazole for use in treating agitation associated with Alzheimer’s dementia. Brexpiprazole was previously approved in 2015 for use as an adjunctive therapy to antidepressants in adults with major depressive disorder and as a treatment
Devices
FDA has cleared a CardiacSense 510(k) for its CSF-3 Watch for monitoring vital signs, such as electrocardiogram, beat-by-beat heart rate, and oxygen saturation of arterial hemoglobin. During 2023, the company says it plans to submit additional data to the agency to support additional intended uses. “Motion
Drugs
While CDER novel drug approvals fell 26% last year to 37 NDAs/BLAs getting the green light, the Center is not worried that this may signal any slowing workload trend at the agency. The 37 approvals are the lowest since 2016 when 22 approval were tallied (see Nature article on
Biologics
BioMarin Pharmaceutical is submitting to FDA additional long-term data (three years) as part of the ongoing BLA review for Roctavian (valoctocogene roxaparvovec), an investigational one-time gene therapy for treating adults with severe hemophilia A. The data submitted show the mean annualized bleed rate reduced by 80% from baseline
Devices
Zyno Medical has agreed to pay $493,000 to resolve allegations that it violated the False Claims Act by causing the submission of claims to Medicare involving the intravenous (IV) administration of medication using the firm’s defective IV administration sets. The settlement resolves allegations that Zyno knowingly distributed defective
Drugs
FDA has accepted a Roche BLA for priority review for glofitamab, an investigational CD20xCD3 T-cell engaging bispecific antibody for treating adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy. FDA has set a user fee review action target date of
Biologics
CDER director Patrizia Cavazzoni is attempting to restore credibility within her Center by announcing the accelerated approval for a Biogen/Eisai BLA for Leqembi (lecanemab-irmb) for treating Alzheimer’s disease (AD), while also addressing previous controversies with the 2021 approval of Biogen’s Aduhelm (aducanumab). Leqembi is the second
Drugs
Hospira has recalled one lot of injectable vancomycin HCl single-dose fliptop 1.5 g vials due to two visible glass particulates observed in a single vial. “If administered intravenously, patients may experience adverse events such as local irritation or swelling, vasculitis/ phlebitis, antigenic or allergic reactions, and microvascular obstruction,
Drugs
FDA has issued Ipsen Biopharmaceuticals a complete response letter on its NDA for palovarotene, an investigational treatment for reducing new abnormal bone formation (heterotopic ossification) in people living with fibrodysplasia ossificans progressiva (FOP). The ultra-rare disease causes permanent and continuous bone formation in soft and connective tissues like muscles,
Devices
The recently signed omnibus legislation contains language to extend a drug company safe harbor to medical device companies on sharing health care economic information to formulary committees and other similar entities prior to receiving FDA approval or clearance. The legislation basically codifies a 2018 FDA guidance on the topic, “providing
Biologics
An FDA update says it is closely monitoring the emergence of the XBB.1.5 Omicron subvariant that is currently estimated to account for 28% of circulating Covid-19 variants in the U.S. “Because of its similarity to variants that are not neutralized by [AstraZeneca’s] Evusheld (e.g.
FDA Policy/General
The FDA Office of Digital Transformation (ODT) has launched a technology-focused Leadership Modernization Action Plan (LMAP), the next step in its enterprise transformation efforts. FDA chief information officer Vin Desai and executive officer Jessica Berrellez write in an FDA Voices online post that the LMAP is “the final piece
Drugs
FDA has published a draft guidance, Controlled Correspondence Related to Generic Drug Development, with information on the process by which generic drug manufacturers and related industry or their representatives can submit to FDA controlled correspondence requesting information related to generic drug development. The document also describes the agency’s process
Drugs
FDA has delayed the 12/23/22 PDUFA action date for the Junshi Biosciences and Coherus BLA for toripalimab to treat recurrent or metastatic nasopharyngeal carcinoma (NPC). The companies say FDA previously communicated that an on-site inspection of the Junshi Biosciences manufacturing facility for toripalimab is required before the
Drugs
FDA has released the form FDA-483 issued following a 5/12-5/20/22 inspection at the Glenmark Pharmaceuticals drug manufacturing facility in Goa, India. The five inspection observations were: * failing to extend investigations of an unexplained discrepancy and a failure of a batch or any of its components