FDA Policy/General
FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below: Vital Rx dba Atlantic Pharmacy and Compounding Pompano Beach, FL (9/26): FDA inspected the firm in July and cited serious deficiencies
Drugs
FDA has accepted a Dova Pharmaceuticals supplemental NDA for Doptelet (avatrombopag) for a new indication — treating chronic immune thrombocytopenia (ITP) in patients who have had an insufficient response to a previous treatment. ITP is an autoimmune bleeding disorder characterized by thrombocytopenia (low platelets level). The second generation, orally administered thrombopoietin
FDA Policy/General
Federal Register notice. FDA is seeking comments on an information collection extension for its “Guidance for Industry on Individual Patient Expanded Access Applications: Form FDA 3926” (OMB Control Number 0910-0814). Individual patient expanded access allows an individual patient who has a serious or immediately life-threatening disease or condition
Drugs
A 6/26-7/20 FDA inspection at Vital Rx, doing business as Atlantic Pharmacy and Compounding, Pompano Beach, FL, found “serious deficiencies” in the firm’s practices for producing drug products, which put patients at risk. A just-released 9/26 notice of violation says drug products were prepared,
Devices
A 10/25 CDRH Webinar explained a recent guidance on appropriate use of voluntary consensus standards in premarket submissions for medical devices. During the program, CDRH director of the standards and conformity assessment program Scott Colburn reviewed the evolution of the guidance from its 2014 draft to changes that were
Drugs
Sandoz has decided not to pursue FDA approval for its proposed biosimilar of rituximab (Genentech’s Rituxan), indicated for treating some non-Hodgkin’s lymphomas. Earlier this year, the agency issued a complete response letter, requesting additional information to complement the submission, the company says. Sandoz says it will focus
Drugs
FDA has issued Lupin a five-item Form 483 after an inspection at the firm’s Madhya Pradesh, India manufacturing plant cited significant GMP violations. For example, FDA said Lupin’s control procedures are not established to monitor the output and validate the performance of those manufacturing processes that may
Devices
FDA has cleared a NinePoint Medical 510(k) to market its Intelligent Real-time Image Segmentation software upgrade for its NvisionVLE Imaging System. The artificial intelligence-based platform for image feature segmentation is intended for use in imaging esophageal tissue. The imaging system allows physicians to perform a volumetric laser
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking.” The document describes FDA’s intention to defer enforcement of unique device identification requirements for Class I and unclassified devices, other
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Biosimilars User Fee Program” (OMB Control Number 0910-0718). The Biosimilar User Fee Act of 2012 authorized FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development. It was reauthorized
Drugs
FDA’s Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee has voted 17 to 1 that data support the benefit-risk profile of Sage’s Zulresso (brexanolone) injection for treating postpartum depression (PPD). Panel members recommended that the drug be administered by qualified staff in a
Devices
FDA has cleared a Shoulder Innovations 510(k) for the InSet Humeral Short Stem System for partial or total shoulder arthroplasty used in the treatment of degenerative, rheumatoid or traumatic arthritis in the shoulder. The system includes streamlined instrumentation and proprietary coating technology for implant fixation with bone preservation, the
Drugs
FDA has issued a safety alert about labels attached to some Pfizer/Mylan EpiPen 0.3mg and EpiPen Jr 0.15mg auto-injectors, which may block access to the auto-injector and prevent the ability to easily access the product. The alert also applies to authorized generic versions of the
FDA Policy/General
Novanta has acquired privately-held Zettlex Holdings and its inductive encoders that can provide absolute and accurate positioning even in extreme operating environments. Novanta says there is a growing demand for precision motion technology in robotics, precision automation and key medical markets. Janssen Biotech has agreed to purchase HC2 Holdings
FDA Policy/General
Draft Guide on Hepatitis B Drugs Federal Register notice: FDA makes available a draft guidance entitled “Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment.” 11/02/2018 Workshop on Hemophilia Product Development Federal Register notice: FDA announces a 12/6 public workshop entitled “Product Development in Hemophilia.” 11/02/
Devices
FDA has classified as Class 1 a Roche Diagnostics recall of its CoaguChek XS PT Test Strips due to inaccurate International Normalized Ratio (INR) test results, when compared to laboratory results. Roche re-calibrated the strips in January to correspond to a newly released INR International Standard. Since the re-
Drugs
FDA has approved an Aquestive Therapeutics NDA for Sympazan (clobazam) oral film for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients two years of age or older. According to the company, Sympazan is the first oral film FDA-approved to treat seizures associated with LGS.
Drugs
Members of the FDA Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee have voted 21 to 2 that the benefit-risk profile was not adequate to support approval of an Alkermes NDA for a combination product containing buprenorphine and samidorphan intended to be used as an
Devices
FDA has posted a guidance on “Unique Device Identification (UDI): Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking.” UDI system requirements are being phased in over seven years according to established compliance dates based primarily on device classification. The guidance outlines FDA’
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment.” The document includes general considerations for nonclinical toxicology and virology studies, early phase clinical development, clinical pharmacology assessments, and Phase 3 safety and efficacy trials. It also discusses Phase 3
FDA Policy/General
Federal Register notice: FDA has announced a 12/6 public workshop entitled “Product Development in Hemophilia.” The workshop is intended to advance further development of patient- experience and patient-reported outcomes for use in clinical trials, facilitate reliable and interpretable measurements of Factor VIII/IX activity levels for gene therapy
Drugs
FDA has approved an AcelRx Pharmaceuticals resubmitted NDA for Dsuvia (sufentanil sublingual tablet, 30 micrograms) for treating moderate-to-severe acute pain in adult patients in medically supervised settings. In 10/2017, the agency issued a complete response letter on the original submission, asking for additional safety-related data from