Drugs
CDER director Janet Woodcock is emphasizing the need for drug compounding outsourcing facilities to appropriately label their drugs with adverse event reporting information and to report events to FDA, or face regulatory and enforcement action if they do not. “We remind outsourcing facilities to develop thorough procedures to compile and
FDA Policy/General
Review Period Determined for Giapreza Federal Register notice: FDA determines the regulatory review period for La Jolla Pharmaceutical’s Giapreza (angiotensin II). 09/06/2019 Guide on Pediatric Partial Onset Seizures Federal Register notice: FDA makes available a final guidance entitled “Drugs for Treatment of Partial Onset Seizures: Full Extrapolation
FDA Policy/General
DEVICES Accuray Inc. has received FDA 510(k) clearance for its Radixact Treatment Delivery Platform and its new treatment planning and data management systems, Accuray Precision Treatment Planning System and iDMS Data Management System. The company says these next generation hardware and software solutions make up the new Radixact system,
Devices
FDA has issued a final guidance entitled “Acceptance Review for De Novo Classification Requests.” The document is intended to provide clarity about the de novo pathway and explains the procedures and criteria the agency will use to determine if such a request meets a minimum threshold of acceptability and should
FDA Policy/General
Federal Register notice: FDA has determined the regulatory review period for patent extension purposes for La Jolla Pharmaceutical’s Giapreza (angiotensin II), a vasoconstrictor for increasing blood pressure in adults with septic or other distributive shock. The review period is 1,639 days, which includes 1,463 days that occurred
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Drugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy from Adults to Pediatric Patients Two Years of Age and Older.” The document addresses FDA’s current thinking regarding clinical development programs that can support extrapolation of the
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Guidance for Industry on E6 (R2) Good Clinical Practice; International Council for Harmonization; Integrated Addendum to ICH E6 (R1).” The guidance is intended to facilitate implementation of improved and more efficient approaches to clinical trial design, including
Devices
FDA has cleared a Bardy Diagnostics 510(k) for its 14-day version of the Carnation Ambulatory Monitor (CAM), a P-wave centric ambulatory cardiac patch monitor and arrhythmia detection device. The device is an extension of the company’s previously cleared two-day and seven-day CAM product lines.
Biologics
Endo International has submitted a BLA for collagenase clostridium histolyticum (CCH) for treating cellulite in the buttocks. The submission is based on data from two identical Phase 3 RELEASE studies that demonstrated a greater percentage of the 843 women treated during the studies met the primary endpoint of response with
Drugs
CDER director Janet Woodcock says addiction currently is the most serious threat to public health. In a 9/6 interview with the Los Angeles Times, Woodcock said the opioid abuse is improving at the moment, but there are many other concerns: “Alcohol abuse. Poly-drug abuse, when people combine multiple
Drugs
FDA has approved Boehringer Ingelheim Pharmaceuticals’ Ofev (nintedanib) capsules to slow the rate of decline in pulmonary function in adults with interstitial lung disease associated with systemic sclerosis or scleroderma. Approval was based on data in 576 patients ages 20-79 with the disease. “Patients received treatment for 52 weeks,
Devices
FDA says it is seeking feedback for 90 days on a discussion paper about a concept that the agency is considering to aid in assessing tolerability of risk in light of varying degrees of benefit for medical devices intended for weight loss. The paper says so far CDRH has approved
Drugs
FDA has issued a guidance, Drugs for the Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy from Adults to Pediatric Patients 2 Years of Age and Older, with recommendations to sponsors on clinical development of drugs for treating partial onset seizures in pediatric patients. Specifically, the document addresses the
Devices
FDA has published two guidances relating to the Humanitarian Device Exemption (HDE) Program. The first guidance, Humanitarian Device Exemption Program, is intended to clarify the current review practices for the HDE program. The document addresses commonly asked questions about HDEs and humanitarian use devices (HUD), including FDA actions on HDE
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Applications for Food and Drug Administration Approval To Market a New Drug: Patent Submission and Listing Requirements” (OMB Control Number 0910-0513). FDA requires all NDA applicants to file, as part of an NDA, the patent number
FDA Policy/General
Federal Register proposed rule: FDA is proposing to amend its list of bulk drug substances (active pharmaceutical ingredients) that can be used to compound drug products to add five additional bulk drug substances to the list. The proposed rule also identifies 26 bulk drug substances that FDA has considered and
Drugs
FDA has issued a grant to VeraSci to conduct further research on its virtual reality functional capacity assessment tool (VRFCAT). The company says the VFRCAT has been accepted into the agency’s clinical outcome qualification program as a measure of functional capacity for schizophrenia treatment trials. It says the project
Drugs
The Justice Department says Mallinckrodt has agreed to pay $15.4 million to resolve claims that when it was known as Questor it paid illegal kickbacks to doctors in the form of lavish dinners and entertainment to induce prescriptions for its H.P. Acthar Gel from 2009 through 2013. The
FDA Policy/General
Based on information from sources familiar with the process, BioCentury is reporting that HHS secretary Alex Azar has sent to the White House the names of three individuals as potential FDA commissioner. The online report identifies them as: * Acting commissioner Ned Sharpless; * University of Texas M.D. Anderson Cancer Center
FDA Policy/General
Former CDER associate director for genomics (2004-2008) Felix Frueh has joined NDA Partners as an expert consultant. At FDA, he led the agency’s first genetic and genomic review division and established the biomarker qualification process and companion diagnostic development policies. In his new role, Frueh will use his
Devices
FDA has cleared a medPhoton 510(k) for the ceiling-mounted ImagingRing, an in-room cone-beam computed tomography imaging system. The 102cm bore system features ceiling rail mounting, and it integrates into the Mevion proton therapy system to allow daily soft tissue localization, the company says. It also pairs
Devices
FDA has cleared an Arthrosurface 510(k) for its BOSS Toe Fixation System, which the company says is intended to improve stabilization in a first metatarsal that presents with a distal bone void and provides patients with a motion-preserving alternative to toe fusion. The device was designed to fill