FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says a Merz Pharmaceutical promotion for Xeomin (incobotulinumtoxinA) for injection, for intramuscular or intraglandular use, featuring paid celebrity spokesman Nate Berkus, makes false or misleading representations and suggestions about the risks and efficacy of the drug. A 10/31 Notice of Violation
Biologics
Adaptimmune Therapeutics says it plans to begin a rolling BLA next year for cell therapy lete-cel in people with synovial sarcoma or myxoid/round cell liposarcoma (MRCLS) who received previous anthracycline-based therapy. The company’s decision to seek marketing approval is based on just-announced positive data from
Drugs
FDA has released the form FDA-483 that was issued following a 6/17-7/2 inspection at the U.S. Specialty Formulations outsourcing facility in Allentown, PA. The seven inspection observations were: * the quality control unit lacks the responsibility and authority to approve and reject all components, drug product
Drugs
FDA has published a draft guidance, Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics, with recommendations on the approaches for the nonclinical safety evaluation of oligonucleotide-based therapeutics (ONTs) to support clinical development and marketing of those products. The document says although current guidance for small molecule drugs and therapeutic proteins
Devices
FDA has cleared a NovaBone Products 510(k) for its bioactive synthetic bone graft, NovaBone Putty, and its expanded use in the intervertebral disc space. The clearance covers the device’s use in the intervertebral disc space alongside FDA-cleared interbody fusion devices, NovaBone says. The company says the device
Biologics
Six Squire Patton Boggs attorneys say that at the end of the Supreme Court’s 2023-2024 term, the court issued four decisions that “have potentially wide-ranging consequences on federal agency rulemaking, adjudication, and regulatory compliance.” Writing in an online post, the attorneys analyze the impact of the decisions
Drugs
DifGen Pharmaceuticals is petitioning FDA to not approve any ANDA for Prednisolone Ophthalmic Solution 1% without the inclusion of long-term stability studies conducted under refrigerated conditions. The 11/7 petition specifically asks that the agency: * require generic applicants to conduct long-term stability studies that specifically demonstrate the product’
Drugs
Federal Register notice: FDA is announcing a 12/13 virtual public workshop entitled “Patient-Focused Drug Development: Workshop to Discuss Methodologic and Other Challenges Related to Patient Experience Data.” It is intended to highlight and discuss methodological issues related to patient experience data, including submitting and evaluating patient experience data
Drugs
Boston Scientific has recalled (Class 1 — use instructions update) its POLARx and POLARx FIT Cryoablation Balloon Catheters because of atrio-esophageal fistula (AE fistula) risks. AE fistula is a known and inherent risk for patients undergoing catheter ablation for atrial fibrillation, according to the company. “Although uncommon, esophageal injury is
Devices
LivaNova says its aura6000 system, indicated to treat obstructive sleep apnea using targeted hypoglossal nerve stimulation, met the primary safety and efficacy endpoints in the OSPREY trial. A company statement describes the aura6000 as an implantable hypoglossal neurostimulator intended to treat adults with moderate to severe obstructive sleep apnea. Once
Drugs
Speaking on a Government Accountability Office (GAO) podcast, GAO healthcare director Mary Denigan-Macauley says FDA needs to have a plan to address all of the causes that make it difficult to recruit facility inspectors and a strategy for retaining new hires. The podcast focuses on foreign and domestic facility
Devices
FDA has cleared a GE HealthCare 510(k) for its Signa Magnus, a 3.0T high-performance, head-only magnetic resonance imaging scanner. The device features an asymmetrical, head-only gradient coil design that “shifts the gradient isocenter to the patient edge of the coil rather than its geometric center,
Devices
An 8/5-8/14 FDA inspection at Owens & Minor, doing business as American Contract Systems, in Mechanicsville, VA, found Quality System Regulation violations in the firm’s manufacturing of sterile convenience kits such as a C-Section Pack. An 11/1 Warning Letter says the specific violations were:
Drugs
An FDA review of records submitted at the agency’s request by the over-the-counter drug producer Zhejiang Qimei Cosmetics Co. in Zhejiang Sheng, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 11/7 Warning Letter says specific violations were: * failure of
Biologics
FDA has accepted for review an Abeona Therapeutics BLA resubmission for prademagene zamikeracel (pz-cel), an autologous cell-based gene therapy for patients with recessive dystrophic epidermolysis bullosa (RDEB). The resubmission follows an April complete response letter that requested additional information to satisfy chemistry manufacturing and controls requirements (see earlier
Drugs
Federal Register notice: FDA has determined that Nuplazid (pimavanserin tartrate) tablet (equivalent 17 mg base) was not withdrawn due to safety or effectiveness concerns. The determination allows the agency to approve ANDAs that reference the product if all other legal and regulatory requirements are met. Nuplazid is an atypical antipsychotic
FDA Policy/General
Federal Register notice: FDA is announcing a 12/12 public workshop titled “Optimizing the Use of Real-World Evidence in Regulatory Decision-Making for Drugs and Biological Products — Looking Forward.” It is intended to provide an update on FDA’s current activities related to real-world evidence and to share
Drugs
The Republican leadership of the House Energy and Commerce Committee is asking the Government Accountability Office (GAO) to “examine the structure of laboratory safety programs” at FDA, the Centers for Disease Control (CDC), and the National Institutes of Health. An 11/12 committee statement (includes a link to a letter
Devices
FDA has sent Warning Letters to two overseas manufacturers of x-ray equipment. The 10/18 letter to Rolence Ent. Inc. in Taoyuan City, Taiwan, follows a 7/8-7/11 inspection there that found Quality System Regulation violations in the manufacturing of the XR-01 portable x-ray system.
Drugs
FDA has issued Intercept Pharmaceuticals a complete response letter on its supplemental NDA for Ocaliva (obeticholic acid) seeking to convert its accelerated approval to full approval for treating patients with primary biliary cholangitis (PBC). The company says that the letter was consistent with a September Gastrointestinal Drugs Advisory Committee meeting
FDA Policy/General
FDA commissioner Robert Califf says he is “personally disappointed” in the election results that will see another Trump administration overseeing the agency. Speaking during a virtual keynote address at the Friends of Cancer Research 11/12, Califf said that “it’s pretty clear that the gist of [the Trump] administration,
Drugs
Eli Lilly says it opposes the request by the Outsourcing Facilities Association (OFA) that tirzepatide (Lilly’s Mounjaro and Zepbound) be added to the “clinical need” list, otherwise known as the 503 Bulks List. A Lilly comment says that OFA seeks permanent authorization for its members to engage in the