FDA Policy/General
Federal Register notice: FDA has reopened the comment period for a 3/1 notice entitled “International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; World Health Organization; Scheduling Recommendations; Dronabinol (delta-9 tetrahydrocannabinol) and its Stereoisomers; Cannabis, Cannabis Resin, Extracts and Tinctures; Cannabidiol Preparations; and Pharmaceutical Preparations
Devices
FDA has cleared a Biobeat 510(k) for its patch and watch for measuring blood pressure, oxygenation and heart rate in hospitals, clinics, long-term care and at home. The company’s smartwatch and patch connect to the cloud through either a smartphone or a dedicated gateway. Users can wear
Drugs
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. CTX Lifesciences, Gujarat, India (7/12): FDA inspected the firm in February and cited significant GMP deviations for active pharmaceutical ingredients (API). For example, CTX failed to ensure that
FDA Policy/General
Attorney Anne Walsh (Hyman, Phelps & McNamara) says a recent Supreme Court decision “significantly cabined the scope and application” of what is known as the Auer deference, which requires courts to defer to FDA’s interpretation of its own regulations if they are ambiguous. Writing in her firm’s FDA
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Male Breast Cancer: Developing Drugs for Treatment.” The document provides recommendations on the development and labeling of cancer drugs for treating male patients with breast cancer. It also provides recommendations on clinical development when males have either not been
Drugs
A recently posted Establishment Inspection Report (EIR) on AveXis’ Zlogensma, a gene therapy product associated with data manipulation allegations, shows an extensive review of a controversial in vivo potency assay (SOP-285) and FDA’s acceptance that problems raised with the assay have been resolved with its discontinuance and the
Drugs
CDER Office of Antimicrobial Products (OAP) director Edward Cox has left FDA to join Regeneron as regulatory affairs vice president. Cox has served as OAP director since 2006, after serving as its deputy director since 2003. OAP deputy director John Farley will serve as acting director until a permanent replacement
Devices
FDA has given Staar Surgical IDE approval to begin a clinical trial for the EVO/EVO+ VISIAN Implantable Collamer Lens for myopia, and EVO/EVO+ VISIAN Toric Implantable Collamer Lens for myopia with astigmatism. Under the IDE, FDA recommended study design modifications, which Staar says it plans to incorporate into
Drugs
A 211-2/16 FDA inspection at CTX Lifesciences, Surat, Gujarat, India, found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API). A just-released 7/12 Warning Letter says specific deviations were: * failing to ensure that water used in the redacted manufacturing steps of a
Drugs
FDA has approved a Kyowa Kirin NDA for Nourianz (istradefylline) tablets as an add-on treatment to levodopa/carbidopa in adult patients with Parkinson’s disease (PD) experiencing “off” episodes, the period when patients’ medications are not working well, which cause an increase in PD symptoms (tremors and difficulty walking)
Drugs
FDA has released the FDA-483 issued following a 5/31 and 6/3-6/7 inspection at First Pharma Associates, Spokane, WA, a producer of sterile and non-sterile drug products. The 10 inspection observations were: * non-microbial contamination was observed in the production area; * personnel were observed manually
Drugs
A 2/25-2/28 FDA inspection at Ningbo Pulisi Daily Chemical Products Co., Ltd., Yuyao City, Zhejiang Province, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and other violations. An 8/13 Warning Letter says specific violations were: * failing to perform, for each
Drugs
FDA has approved Eli Lilly’s Taltz (ixekizumab) injection 80 mg/mL for treating adults with active ankylosing spondylitis (AS), also known as radiographic axial spondyloarthritis. The drug was initially approved 3/2016 for treating moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or
FDA Policy/General
Federal Register notice: FDA has announced a 10/9 Vaccines and Related Biological Products Advisory Committee meeting. Panel members are scheduled to hear an overview of the research programs from CBER’s Laboratory of Hepatitis Viruses and the Laboratory of Vector-Borne Viral Diseases. They will also discuss and make
Drugs
FDA commissioner Ned Sharpless says that it plans to release a final guidance on developing amyotrophic lateral sclerosis (ALS) drugs and biologics products by the end of September. “Patients are at the forefront of everything we do, and FDA remains deeply committed to supporting the (ALS) community in its efforts
Drugs
A new report from FDA says that from 4/1/1999 to 8/31/2018 there were 548 orphan indications approved. Of these, FDA identified 200 orphan indications that did not warrant pediatric labeling (adult only indications or indications for which pediatric studies were impossible or highly impracticable). “Of the
FDA Policy/General
A just-released FDA Warning Letter cites Metuchen Pharmaceuticals over its promotional activities related to erectile dysfunction drug Stendra (avanafil) tablets. CDER Office of Prescription Drug Promotion (OPDP) says a direct-to-consumer print ad and display banners make false or misleading claims about the risks associated with the drug.
Drugs
FDA wants to start seeing more males included in breast cancer drug trials and using real world data can help. A draft guidance, Male Breast Cancer: Developing Drugs for Treatment, has been released that provides recommendations on how additional data to support efficacy and safety for male patients with breast
Drugs
FDA has approved an Akorn ANDA for azelastine hydrochloride nasal spray, 0.15%, indicated for relieving symptoms of seasonal allergic rhinitis and perennial allergic rhinitis in patients six years of age and older. U.S. annual sales of azelastine hydrochloride nasal spray are about $18 million. The product will be
Devices
FDA has cleared a Vyaire Medical 510(k) for two of its latest pulmonary function testing (PFT) technologies: Vyntus ONE and Vyntus BODY with SentrySuite Software. Vyntus ONE is designed to be a convenient PFT station available in a fixed or mobile configuration, the company says, and Vyntus BODY is
Drugs
Oklahoma county judge Thad Balkman ruled 8/26 against Johnson & Johnson in the state’s opioid trial, saying the company must pay $572 million in the first ruling in the U.S. holding a drugmaker responsible for helping fuel the opioid epidemic. The judge called the opioid crisis an
FDA Policy/General
Panel to Discuss Chikungunya Vaccine Development Federal Register notice: FDA announces an 11/8 Vaccines and Related Biological Products Advisory Committee meeting to discuss chikungunya vaccine development. 08/23/2019 Correction on Opioids Hearing Federal Register notice correction: FDA corrects a 6/21 notice entitled “Standards for Future Opioid Analgesic