Drugs
FDA has issued ITM Isotope Technologies Munich SE a Complete Response Letter (CRL) for its NDA for ¹⁷⁷Lu-edotreotide (ITM-11), an investigational radiopharmaceutical for gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The agency letter says the submission could not be approved in its current form due to chemistry, manufacturing and controls
Drugs
Abiomed and manufacturing partner Oscor have issued a correction (Class 1 recall) for certain catheter introducers used with Impella heart pumps after identifying a potential for leakage that could result in serious bleeding, according to an FDA notice. The introducers are intended to provide access for introducing catheters into the
Drugs
Sarah Ibrahim has been appointed CDER deputy center director for Regulatory Programs, a role she has been serving in an acting capacity since January. In this role, Ibrahim serves on CDER’s senior leadership team and supports the Center director by providing executive leadership on strategic initiatives that advance CDER’
Drugs
Senators Jim Banks (R-IN) ) and Cory Booker (D-NJ) have introduced the bipartisan Prescription Information Modernization Act to allow drug makers to distribute prescribing information electronically while retaining the option to receive paper copies. Current laws require prescribing information — including dosing instructions, drug interactions, precautions for pregnant women, pediatric
Drugs
Primus Pharmaceuticals has resubmitted a petition to FDA seeking specific actions on ANDAs for a generic form of the company’s Impoyz (clobetasol propionate) 0.025% topical cream, which is indicated for moderate to severe plaque psoriasis. The petition notes the petition was originally submitted in 2020 by Encore Dermatology,
Drugs
FDA has cited Emcure Pharmaceuticals' sterile injectable manufacturing facility in Ahmedabad, India, for multiple GMP deficiencies following an inspection conducted in May, according to a just-posted Form 483. The nine-page inspection report contains seven observations covering equipment qualification, complaint investigations, laboratory controls, aseptic processing, contamination controls and
Drugs
FDA is asking small dispensers under the Drug Supply Chain Security Act to complete an assessment that will evaluate their ability to conduct interoperable tracing of product at the package level. An agency announcement (contains a link to the assessment) says FDA encourages dispensers with 25 or fewer full-time
Drugs
Eight House Democrats are asking FDA to address estrogen patch shortages for menopause treatment. The seven — Reps. Debbie Dingell (D-MI), Deborah Ross (D-NC), Eleanor Holmes Norton (D-DC), Andrea Salinas (D-OR), Jesus Garcia (D-IL), Yvette Clark (D-NY), Rashida Tlaib (D-MI), and Emily Randall (D-
Drugs
FDA appears to be signaling that increased regulatory oversight might be on the horizon for unapproved animal-derived thyroid medications, which are used by an estimated 1.5 million Americans to treat hypothyroidism. The agency says it plans to issue new draft guidance outlining its enforcement priorities for such products.
Drugs
A 59% surge in FDA drug Warning Letters in 2025 over 2024 is not the result of isolated mistakes but rather “is the predictable outcome of a structural problem the industry has tolerated for too long.” That’s the view of Krieger Scientific founder and CEO Joseph Morwald, as expressed
Drugs
FDA has accepted for review a Merck supplemental BLA for Enflonsia (clesrovimab-cfor) to expand its indication to include preventing respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in children under age two years at increased risk for severe RSV disease through their second RSV season. The agency has
Drugs
Two senior U.S. senators are seeking answers from FDA about its plans to address ongoing shortages of several critical chemotherapy drugs. In an 8/5 letter to FDA acting commissioner Kyle Diamantas, Sens. Rick Scott (R-FL) and Kirsten Gillibrand (D-NY) requested a briefing by 9/4 on
Drugs
FDA is continuing to outline its intention to overhaul the early-stage clinical development process through a planned Expedited IND Pilot, arguing that the changes are needed to prevent drug development from shifting overseas and to accelerate first-in-human clinical trials in the U.S. In an 8/5
Drugs
FDA has issued a Request for Information (RFI) seeking feedback from industry, academia, healthcare providers, patient groups, and other interested parties on identifying critical community needs and establishing mechanisms for continuous engagement, supporting collaborative demonstration projects or research on innovative approaches aimed at addressing high-priority areas through the application
Drugs
Minutes of a Type C meeting between FDA and Tonix Pharmaceuticals show the agency and company aligned on the protocol for an adaptive Phase 2 study of Tonix’ TNX-4800 (human anti-outer-surface protein A monoclonal antibody) to prevent Lyme disease in adults. A company statement says the adaptive
Drugs
FDA has cited multiple manufacturing and quality system deficiencies at a Zydus Lifesciences Limited sterile manufacturing facility in Ahmedabad, Gujarat, India, including concerns related to aseptic processing controls, environmental monitoring, airflow studies and data review procedures, according to a just -posted FDA Form 483 issued following a 4/25-5/
Drugs
FDA has approved Takeda’s Orzeyful (oveporexton) tablets to treat narcolepsy type 1 in adults. An agency statement says Orzeyful is the first medicine approved for narcolepsy type 1 as a complete disorder, addressing the full range of symptoms that define the condition. It is the first drug to work
Drugs
Fresenius Kabi is recalling (Class 1) one lot of Simplist (morphine sulfate injection USP) 2 mg/1 mL prefilled syringes after discovering a labeling mix-up that could result in patients receiving hydromorphone. According to Fresenius Kabi, a MicroVault labeled as morphine sulfate injection 2 mg/1 mL may contain
Drugs
An FDA review of records requested from Thomas Brunner GmbH, a Baden-Württemberg, Germany, over-the-counter drug manufacturer, identified significant violations in the firm’s manufacturing of misbranded, unapproved drugs. A 7/24 Warning Letter lists these violations of the Federal Food, Drug, and Cosmetic Act: * failure to have,
Drugs
Jazz Pharma says it will seek FDA approval to remove Zepzelca’s (lurbinectedin) second-line metastatic small cell lung cancer (SCLC) indication based on data from the company’s LAGOON trial. In June, Jazz reported (see earlier story) that the confirmatory study failed to meet its primary endpoint of overall
Drugs
Liebel-Flarsheim is recalling (Class 1) one lot of its Optiray Imaging Bulk Package 350 radiographic contrast agent after identifying particulate contamination that could pose serious health risks if injected. A recall notice says the affected lot contains particulate matter identified as polyethylene and other plastic materials, stainless steel and
Drugs
The International Council for Harmonization (ICH) M8: Electronic Common Technical Document (eCTD) Implementation Working Group has issued updated support materials for eCTD v4.0. An ICH statement (contains links to the support materials) says the updates cover the implementation guide package, the controlled vocabulary package, and the Q&A