Devices
FDA has granted de novo marketing for Natural Cycles Nordic’s Natural Cycles mobile medical application that can be used as a method of contraception to prevent pregnancy. The app contains an algorithm that calculates the days of the month a woman is likely to be fertile based on daily
Devices
Hologic’s Cynosure division has suspended marketing and distribution of its TempSure Vitalia handpiece and probe, which is used for heating vaginal tissue, due to FDA concerns regarding “vaginal rejuvenation” procedures using energy-based devices (see earlier story). Last month, FDA warned that using energy-based medical devices to perform
Drugs
Eastern Pennsylvania federal court has denied a Johnson & Johnson motion to dismiss an antitrust civil action brought by Pfizer over infliximab. The 2017 suit alleges that Johnson & Johnson engaged in anticompetitive practices (exclusive agreements and bundled rebates to shield Remicade from Pfizer’s biosimilar product, Inflectra. In the
Devices
FDA has cleared a 7D Surgical 510(k) for the Cranial Module for use on its Machine-vision Image Guided Surgery (MvIGS) system for cranial surgery. The device uses the company’s new camera-based technology and machine vision algorithms to eliminate “long-standing frustrations with legacy surgical navigational platforms,
Drugs
FDA has proposed a new “Experimental Study of Risk Information Amount and Location in Direct-to-Consumer (DTC) Print Ads” that is intended to research regulatory requirements for fair balance and the brief summary. Specifically, the agency wants to know if repeating warnings in the Important Safety Information (ISI) section
Drugs
FDA has accepted for review a UCB NDA for midazolam nasal spray, an investigational product for the acute treatment of seizures in patients who require control of intermittent bouts of increased seizure activity (e.g. seizure clusters, acute repetitive seizures). The submission is based on data from the Phase 3
FDA Policy/General
Workshop on Human Skin Safety Testing for Topicals Federal Register notice: FDA announces a 9/10 public workshop entitled “Human Dermal (Skin) Safety Testing for Topical Drug Products: Regulatory Utility and Evaluation.” 08/10/2018 FDA Proposes New Drug Promotion Study on Disclosures Federal Register notice: FDA submits to OMB
Drugs
FDA has released a new draft guidance that is intended to modernize clinical trial designs in oncology drug development. “The approach we’re describing in new guidance today is to help innovators to evaluate drugs in trials that are potentially lower cost, more efficient, and could enable us to learn
FDA Policy/General
Federal Register notice: FDA has announced a 9/10 public workshop entitled “Human Dermal (Skin) Safety Testing for Topical Drug Products: Regulatory Utility and Evaluation.” The workshop is intended to provide a forum to discuss the current state and future directions of the collection of human data on potential skin
Drugs
FDA has approved an Alnylam Pharmaceuticals NDA for Onpattro (patisiran) infusion for treating peripheral nerve disease (polyneuropathy) caused by hereditary transthyretin-mediated amyloidosis (hATTR) in adult patients. This is the first FDA approval of a new class of drugs called small interfering ribonucleic acid (siRNA). “This approval is part of
FDA Policy/General
Federal Register notice: FDA has submitted to OMB a new information collection study entitled “Disclosures in Professional and Consumer Prescription Drug Promotion” (OMB Control Number 0910-New). The proposed research will examine the effectiveness of clear and conspicuous disclosures in prescription drug promotion directed to both healthcare professionals and consumers.
Drugs
FDA has approved a Population Council NDA for Annovera (segesterone acetate and ethinyl estradiol vaginal system), the first vaginal ring contraceptive that can be used for an entire year. The reusable donut-shaped, non-biodegradable, flexible vaginal system is placed in the vagina for three weeks followed by one week
Devices
Spacelabs Healthcare has recalled the Arkon Anesthesia Delivery System due to the device going into a “failed state,” which causes the mechanical ventilation function to stop working. The device is intended for use in hospitals and operating rooms, and it delivers oxygen, air, and nitrous oxide in a controlled manner
Devices
Vyaire Medical has recalled its AirLife Resuscitation Device due to a manufacturing error which may cause extra plastic material in the oxygen output connection that may reduce or block the flow of oxygen to the patient. The blocked connection may result in a delay in or inability to provide necessary
Drugs
Three FDA researchers writing in the online PLOS journal have found a significant increase in the development of new tropical disease drugs after Congress enacted the priority review voucher legislation. They note data showing increases for both high- and low- prevalence conditions. In the post-voucher period, development has centered
Drugs
FDA has outlined its planned “Complex Innovative Designs (CID) Pilot Meeting Program” that is intended to advance the use of complex adaptive, Bayesian, and other novel clinical trial designs. Mandated in the latest user fee agreement, the program offers sponsors an opportunity to meet with CDER/CBER staff to discuss
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances.” The document describes when a standard release test and criteria may be used in lieu of extensive method development and acceptance
FDA Policy/General
Federal Register notice: FDA has determined that Prolixin (fluphenazine hydrochloride) tablets, 1 mg (mg), 2.5 mg, 5 mg, and 10 mg, were not withdrawn from sale for reasons of safety or effectiveness. The determination will allow the agency to approve ANDAs that reference the products if all other legal
Drugs
The American Society of Clinical Oncology and the Friends of Cancer Research have submitted to FDA recommended language for five guidance documents to broaden eligibility criteria for cancer clinical trials. The groups say (includes link to submission package) the recommendations are part of their collaboration to broaden eligibility for participating
FDA Policy/General
FDA says it wants to do research to determine how useful disclosures regarding prescription drug information are when presented prominently and adjacent to claims in print ads. An 8/9 Federal Register notice says the specific question to be examined is whether healthcare professionals and consumers are able to use
Devices
FDA says it is extending from 9/24/18 to 9/24/19 the compliance date for GUDID (Global Universal Device Identifier Database) submission requirements of device constituents of co-packaged combination products assigned to CDER for premarket review. A CDRH letter to manufacturers says the Center is deploying enhancements
Drugs
FDA has announced a 9/10 public workshop entitled “Human Dermal (Skin) Safety Testing for Topical Drug Products: Regulatory Utility and Evaluation” that is intended to provide a forum to discuss the current state and future directions of the collection of human data on potential skin toxicity associated with such