Drugs
FDA has issued a draft guidance on “Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act” that discusses the agency’s interpretation of the statutory phrase “bulk drug substances for which there is a clinical need.” It also
Devices
Becton Dickinson has recalled its BD Vacutainer Blood Collection Tubes with lavender, tan, pink and green rubber tube stoppers due to a chemical in the stopper that interferes with the accuracy of Anodic Stripping Voltammetry (ASV) testing methodology. ASV is the methodology used in Magellan Diagnostics’ LeadCare Testing Systems that
FDA Policy/General
Federal Register notice: FDA has announced a 5/2 Antimicrobial Drugs Advisory Committee meeting. Panel members are scheduled to review and vote on an Achaogen NDA for plazomicin, indicated for treating complicated urinary tract infections and blood stream infections in adults. To view the notice, click here.
Devices
FDA has cleared an Auris Health 510(k) for the Monarch Platform to assist with diagnostic and therapeutic bronchoscopic procedures for treating lung cancer. The device is designed to enable accurate diagnoses and treatment of small and hard-to-reach nodules in the periphery of the lung, the company says.
Devices
FDA has cleared a Delta Med 510(k) for the DeltaVen Closed System Catheter. The peripheral intravenous device has a needle, extension tubing, and an option for a needleless connecter to the catheter. It will be available in a variety of sizes and configurations, including the only 26 gauge safety
Drugs
After consulting with FDA, AbbVie has decided to not seek accelerated approval for Rova-T (rovalpituzumab tesirine) as a third-line treatment for relapsed/refractory small cell lung cancer based on the magnitude of effects across multiple parameters in a single-arm study. “Although the results from the study were
FDA Policy/General
Federal Register notice: FDA has announced a 6/25-26 public symposium entitled “2018 Center for Biologics Evaluation and Research Science Symposium” to discuss scientific topics related to biologic regulation, and highlight science conducted at CBER. Specifically, how scientific research informs regulatory decision making. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced OMB approval of several information collections that include two drug compounding guidances, and state petitions for exemptions from preemption, among others. To view the notice, click here.
Drugs
The House passed a right-to-try bill late 3/21 that would allow terminally ill patients access in certain circumstances to experimental therapies (see earlier story). The bill passed on a vote of 267-149, with 35 Democrats supporting the measure and two Republicans against it. It now heads
Drugs
FDA commissioner Scott Gottlieb says the agency is analyzing opioid analgesic dispensing and refill patterns by medical indication and provider specialty and obtaining important insight into the amount of opioid analgesic that patients appear to need to control acute pain by medical indication. In 3/21 testimony before the House
Devices
Unexpected heating of laser delivery probes has led to a Monteris Medical recall of its NeuroBlate system and laser delivery probes. The system is used during brain surgery to ablate, coagulate, or necrotize brain tissue cells. The recall covers 52 devices manufactured and distributed between 4/2013 and 7/2017.
Drugs
FDA has released the FDA-483 with five observations from a 3/5-3/9 inspection at the Dr. Reddy’s Laboratories active pharmaceutical ingredient (API) manufacturing facility in Medak, Telengana, India. The observations were: * failing to fully follow responsibilities and procedures applicable to the quality control unit; * failing to
Drugs
FDA has approved an expanded indication for Novartis’ Tasigna (nilotinib) to include treatment of first- and second-line pediatric patients aged one year or older with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP). Previously, the product was approved for treating adult patients with newly
Drugs
FDA says a Drugs@FDA Express mobile application is now available through iTunes and Google Play. On the mobile app, users can search for information about FDA-approved branded and generic prescription and over-the-counter drugs and biological therapeutic products. The agency says the Express app is a streamlined
Biologics
CBER has released a list of 12 guidance documents in three categories it plans to publish during the 2018 calendar year. The document says the list includes topics that currently have no guidance associated with them, topics where updated guidance may be helpful, and topics for which CBER has already
Devices
FDA says that based on studies conducted by Becton Dickinson (BD), it continues to recommend that Magellan Diagnostics lead tests not be used with blood samples taken from the vein. A statement by CDRH Office of In Vitro Diagnostics and Radiological Health acting director Donald St. Pierre says that Magellan’
FDA Policy/General
The House and Senate 3/22 passed a fiscal year 2018 omnibus budget bill that will increase FDA’s budget authority (BA) by $41 million (1.5%) over FY 2017. The Alliance for a Stronger FDA welcomed the increase, noting that any boost to FDA’s bottom line is a
Drugs
FDA has cleared an Orthofix International 510(k) for its new internal fixation system, the G-Beam Fusion Beaming System, intended for use in treating Charcot foot, a debilitating condition where the bones in the foot weaken and collapse. The device is designed to be implanted in the medial and
Devices
FDA says it is aware from medical device reports of 414 cases of breast-implant associated anaplastic large cell lymphoma (BIA-ALCL) as of 9/30/17, including the death of nine patients. The new figure is in an agency online update on BIA-ALCL and agency recommendations for healthcare
Drugs
Attorney Mark Schwartz (Hyman, Phelps & McNamara) says in an online post in his firm’s FDA Law Blog that the FDA quality metrics reporting program first announced in 2015 now appears to be on hold. Although the agency had said in 11/2016 that it intended to open an
Drugs
FDA has approved a Sun Pharmaceutical Industries NDA for Ilumya (tildrakizumab-asmn) for treating adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The drug selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor, which
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Postmarketing Safety Reporting for Combination Products.” The draft guidance addresses certain means by which applicants may comply with the 12/2016 final rule on postmarketing safety reporting requirements for combination products. To view the notice, click here.