Drugs
An 11/8-11/16/18 FDA inspection at Spectrum Laboratory Products, Gardena, CA, found CGMP and other violations in the firm’s manufacturing of active pharmaceutical ingredients (API). A 6/4 Warning Letter says the CGMP violations were: * failing to transfer all quality or regulatory information received from the
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it strongly supports involvement of patients, their caregivers, and advocates in the rare disease drug development process and it commends FDA for the format and construct of a 4/29 public meeting it held on the subject. The association’s letter says
Drugs
CDER Office of Medical Policy health science policy analyst Lauren Milner says a new agency draft guidance on submitting documents using real-world data (RWD) and real-world evidence (RWE) to FDA for drugs and biologics is needed because the availability of such data and evidence has created interest within
FDA Policy/General
Federal Register notice: FDA is publishing a list of information collections that have been approved by OMB. To view the notice, click here.
Drugs
Eli Lilly says data from its REWIND study, a cardiovascular (CV) outcomes trial involving diabetes drug Trulicity (dulaglutide), showed a significant 12% reduction in major cardiovascular events (MACE), a composite endpoint of non-fatal myocardial infarction (heart attack), non-fatal stroke or CV death. “REWIND data showed a consistent MACE
FDA Policy/General
Federal Register notice: FDA has determined that Johnson & Johnson’s Nizoral (ketoconazole) topical cream 2% was not withdrawn from sale for safety or effectiveness reasons. The determination allows FDA to continue to approve ANDAs that reference the product as long as they meet relevant legal and regulatory requirements. Nizoral
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Investigational Device Exemptions Reports and Records” (OMB Control Number 0910-0078). To view the notice, click here.
Devices
GE Healthcare says artificial intelligence/machine learning (AI/ML) “is set to revolutionize healthcare. Device manufacturers are embracing AI/ML to create new medical devices and transform the way medical devices function in the healthcare environment.” Responding to an FDA discussion paper and request for feedback, the company says the
Devices
A 6/11-7/5/18 FDA inspection at OriGen Biomedical, Austin, TX, for Quality System Regulation and Medical Device Reporting violations in the firm’s manufacturing of dual lumen catheters, including the Reinforced Dual Lumen ECMO catheter. A just-released 12/20/18 Warning Letter says specific violations were:
Devices
FDA has cleared an EmCyte 510(k) for its PureBMC Supraphysiologic Concentrating System for the safe and rapid preparation of platelet concentrate and cell concentrate from a small sample of bone marrow aspirate through centrifugation. Bone marrow’s platelet and cell concentrate is the strongest autologous biologic prepared at the
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of six ANDAs from multiple applicants after they notified the agency in writing that the products were no longer marketed and requested that they be withdrawn. To view the notice, click here.
Drugs
As reported by NBC News, Kaiser Health News says FDA’s approval of Janssen’s Spravato (esketamine) raises questions about “how drugmakers can take advantage of shortcuts in the FDA process with the agency’s blessing and maneuver through safety and efficacy reviews to bring a lucrative drug to market.
FDA Policy/General
Federal Register notice: FDA has reopened the comment period on a 2/17 Federal Register notice entitled “Quality Considerations for Continuous Manufacturing; Draft Guidance for Industry; Availability.” The agency is allowing interested parties additional time to submit comments, which are now due by 8/10. To view the notice, click
FDA Policy/General
Federal Register notice: FDA has announced an 11/18 The public workshop entitled “Development of Best Practices in Physiologically Based Pharmacokinetic (PBPK) Modeling to Support Clinical Pharmacology Regulatory Decision-Making.” The workshop is intended to discuss best practices and evidentiary criteria for using such modeling approaches; share experiences and cases
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “FDA Safety Labeling Change — Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act” (OMB Control Number 0910-0734). FDA regulations permit the agency to order labeling changes if it becomes aware of
Drugs
An FDA inspection last month at Aurobindo Pharma’s Telangana, India manufacturing facility has led to a nine-observation Form 483. The inspection cited the firm’s quality control unit because its procedures and responsibilities are not in writing and fully followed. FDA also cited the firm for not retaining
Devices
FDA has cleared a Masimo 510(k) for its O3 Regional Oximetry for use on neonatal and infant patients. The device is intended to help clinicians monitor cerebral oxygenation in situations where peripheral pulse oximetry alone may not be fully indicative of the oxygen in the brain, Masimo says The
Biologics
FDA has granted Genentech accelerated approval on a BLA for Polivy (polatuzumab vedotin-piiq), in combination with the chemotherapy bendamustine and a rituximab product (also known as BR) for treating adult patients with diffuse large B-cell lymphoma (DLBCL) that has progressed or returned after at least two prior therapies.
Drugs
CDER’s Office of Compliance has set up a new compounding team with responsibility for the overall management of the agency’s drug compounding compliance program. According to an email from CDER director Janet Woodcock, Division of Compounded Drugs director Gail Bormel will lead the team and report directly to
Drugs
Provention Bio says that a recent study showed that a single 14-day course of PRV-031 (teplizumab) significantly delayed the onset and diagnosis of clinical Type 1 diabetes compared to placebo by a median of two years in children and adults considered to be at high risk. “During the
FDA Policy/General
Workshop on Generating Real-World Evidence Federal Register notice: FDA announces a 7/12 public workshop entitled “Leveraging Randomized Clinical Trials to Generate Real-World Evidence for Regulatory Purposes.” 06/07/2019 Nonalcoholic Steatohepatitis Drug Development Guide Federal Register notice: FDA makes available a draft guidance entitled “Nonalcoholic Steatohepatitis with
FDA Policy/General
DEVICES Medtronic has received approval from FDA for the Prestige LP Cervical Disc System for treating single-level cervical disc disease (radiculopathy and/or myelopathy). Quidel Corp. has received FDA clearance to market its AmpliVue GAS Assay for the qualitative detection of Group A β-hemolytic Streptococcus (Streptococcus pyogenes) nucleic