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
Drugs
The Combination Products Coalition says it has some concerns and suggestions for improvement in a draft FDA guidance on instructions for use (IFU) in patient labeling for combination products. The coalition’s comment letter recommends that the agency revise the document to: * clarify that the final layout and content of
Drugs
An analysis by the Pew Charitable Trusts finds that “it is clear that there are too few [antibiotic] drugs in development to meet current and anticipated patient needs.” The Pew issue brief shows 42 new antibiotics currently in development. “These drugs would potentially address many, but not all, resistant bacteria,
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Current Good Manufacturing Practice (CGMP) for Positron Emission Tomography (PET) Drugs” (OMB Control Number 0910-0667). The CGMP requirements require written procedures as well as recordkeeping related to ongoing manufacturing of individual PET drugs, testing, and product
FDA Policy/General
Representatives of 57 healthcare advocacy organizations and four former FDA commissioners have written to President Donald Trump and HHS secretary Alex Azar urging that they nominate FDA acting commissioner Ned Sharpless to become the permanent commissioner. Under federal regulations, Sharpless can only serve as acting commissioner until early November, the
FDA Policy/General
Federal Register notice: FDA has announced an 11/6-7 General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee meeting. On both days, panel members will discuss industrial ethylene oxide (EtO) sterilization of medical devices and its role in maintaining public health as well as the
Drugs
FDA has issued a guidance, Evaluation of Internal Standard Responses during Chromatographic Bioanalysis: Questions and Answers, with recommendations for sponsors, applicants, and contract research organizations about internal standard (IS) response variability in chromatographic analytical data submitted in INDs, NDAs, ANDAs, BLAs, and supplements. The document says that chromatographic analytical methods
Drugs
Former FDA principal deputy commissioner Rachel Sherman has been appointed to Aptinyx’s board of directors. The clinical-stage biopharmaceutical company is developing therapies for treating brain and nervous system disorders. “The company’s NMDA receptor platform, rooted in novel chemistry and a unique mechanism for modulation of a critical
Drugs
FDA says it recently approved changes to Gilead’s Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) labeling to include new dosage forms and use in pediatric patients three years of age to less than 12 years of age. An online post summarizes the changes for each product. Sovaldi is now
Drugs
Researchers from the University of Pittsburgh and Veterans Health Administration (VHA) say that prescriptions for Pfizer’s Chantix (varenicline) fell following FDA drug safety communications and a Boxed Warning. The research, published online at JAMA Network Open, says that FDA drug safety communications often are based on limited evidence of