Devices
FDA has issued three medical device-related draft guidances about the agency’s Accreditation Scheme for Conformity Assessment Program. They are: * The Accreditation Scheme for Conformity Assessment (ASCA) Program — FDA announces that it has concluded its earlier ASCA pilot phase and is establishing an ongoing ASCA Program. FDA believes the
Biologics
FDA has approved a Sanofi-Aventis supplemental BLA for Sarclisa (isatuximab-irfc) for use with bortezomib, lenalidomide, and dexamethasone for adults with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant. Approval was based on data from the IMROZ (NCT03319667) Phase 3 trial in 446 patients
FDA Policy/General
Federal Register notice: FDA is proposing to revoke the regulations entitled “Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and The European Community.” The action is being proposed because the existing regulations have been superseded
Biologics
FDA has approved a Johnson & Johnson supplemental BLA for Rybrevant (amivantamab-vmjw) in combination with standard-of-care chemotherapy (carboplatin and pemetrexed) for treating adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or L858R substitution
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of nine ANDAs from multiple applicants after they told the agency that the products are no longer marketed. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision entitled “Postmarketing Adverse Experience Reporting.” The collection was revised in response to the Covid-19 public health emergencyto provide recommendations for recordkeeping applicable to any pandemic, not just influenza, including recommendations for planning, notification, and documentation for continuity
Devices
Smiths Medical is recalling (Class 1) its ParaPAC plus P300 and P310 ventilators due to the possibility that patient outlet connectors may become loose or detach altogether, which will impact active ventilation. “If the patient outlet connector is loosened or detached it could cause extended interruption of therapy, no ventilation,
Drugs
Vanda Pharmaceuticals is criticizing FDA for failing to approve the company’s NDA for tradipitant to treat the symptoms of gastroparesis. A company statement says FDA issued a complete response letter that “was conclusory in nature, generally disregarded the evidence provided and instead suggested that Vanda conduct additional studies with
FDA Policy/General
Federal Register notice: FDA is announcing a 10/10 Vaccines and Related Biological Products Advisory Committee meeting to discuss and make recommendations on the strain selection for the 2025 influenza virus vaccines for the southern hemisphere. Panel members are also scheduled to discuss pandemic preparedness for highly pathogenic avian influenza
Drugs
Bionpharma has recalled (Class 1) a single Batch (#2310083) of atovaquone oral suspension, 750mg per mL, due to contamination with Cohnella bacteria. The product was manufactured by CoreRx in Clearwater, FL and distributed by Bionpharma, a recall notice says. The quinone antimicrobial drug is indicated for preventing pneumocycstis jirovecii pneumonia
Devices
FDA has published a draft guidance, Chemical Analysis for Biocompatibility Assessment of Medical Devices, describing recommended methodological approaches for chemical analysis for biocompatibility assessment of medical devices. The document says the recommendations are intended to improve the consistency and reliability of analytical chemistry studies and are based on FDA’s
FDA Policy/General
Federal Register notice: FDA has submitted to OMB information collection revisions entitled “Medical Device User Fee Cover Sheet, Form FDA 3601” and “Device Facility User Fee Cover Sheet, Form FDA 3601a.” Form FDA 3601 is designed to provide the minimum necessary information to determine whether a fee is required to
FDA Policy/General
Appearing at a Wisconsin live program led by Tucker Carlson, former presidential candidate and now Trump supporter and transition team member Robert F. Kennedy, Jr., said he has been asked by Trump to recommend people to head FDA, the Centers for Disease Control, and the National Institutes of Health, Mediaite
Drugs
CDER director Patrizia Cavazzoni and Office of Therapeutic Biologics and Biosimilars director Sarah Yim say a new guidance indicates that a clinical switching study is generally no longer needed to demonstrate interchangeability between a biosimilar and its reference product. Writing in a JAMA Viewpoint, the two say that as the
FDA Policy/General
FDA has approved Elanco Animal Health’s Zenrelia (ilunocitinib tablets), a once-daily oral JAK inhibitor for controlling itching associated with allergic dermatitis and atopic dermatitis in dogs at least 12 months of age. “Zenrelia targets itch where it starts by blocking the pathways involved in allergic itch to break
Drugs
FDA has issued Laboratorios Farmaceuticos Rovi a four-item Form FDA-483 after inspecting the company’s Madrid, Spain manufacturing facility and documenting significant GMP deficiencies. For example, the agency cited the firm over its written records about its investigations into unexplained discrepancies because they do not always include the
Devices
FDA has cleared a Forest Devices 510(k) for the SignalNED Model RE System, a device that uses electroencephalogram (EEG) technology to analyze a patient’s brain to provide clinicians with relevant information about their neurologic state. It “utilizes a novel, rapidly deployed EEG headset (the Sensor Cap) along with
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Conducting Clinical Trials With Decentralized Elements” that provides recommendations on trial-related activities that can occur remotely at locations convenient for trial participants (e.g., telehealth visits with investigators or visits with local healthcare providers). The document also addresses
Devices
Braun Medical is expanding an earlier recall to add lnfusomat Space Infusion System/Large Volume Pump to previous recalled devices — Infusomat Space Large Volume Pump Wireless, and lnfusomat Space Large Volume Pump Non-Wireless Battery Pack — due to the risk that an alarm may sound to indicate an occlusion when
Drugs
FDA has just released the forms FDA-483 issued following an 8/26-9/6 inspection at Granules India Limited in Telangana, India, and a 7/25-8/2 inspection at Gland Pharma Limited Units I&II, also in Telangana. Both companies are listed as manufacturing human drugs. The
Drugs
Joint comments from AbbVie, Genentech, and Johnson & Johnson on a draft guidance about pediatric inflammatory bowel disease (IBD) drug development question why FDA does not allow broader use of extrapolating adult data to determine an appropriate dose for pediatric patients. “We recommend that the agency re-evaluate the need
Drugs
Sens. Marco Rubio (R-FL) and Angus King (I-ME) are urging FDA to develop clear regulatory guidelines for advanced manufacturing technologies (AMT) for drugs. In a statement (contains the text of their letter to FDA commissioner Robert Califf), the senators say that with “insufficient levels of domestic pharmaceutical manufacturing,