Drugs
Ultragenyx Pharmaceutical has submitted to FDA an NDA for UX007 (triheptanoin) for treating long-chain fatty acid oxidation disorders (LC-FAOD), a group of genetic disorders in which the body is unable to convert long-chain fatty acids into energy. The submission is based on data from a Phase 2
FDA Policy/General
A CooperSurgical 30-second TV spot for its ParaGard intrauterine copper contraceptive makes false and misleading representations about the product’s risks, according to a 7/25 Untitled Letter from the CDER Office of Prescription Drug Promotion (OPDP). The letter says OPDP’s Bad Ad Program also received a complaint
Drugs
FDA has made available a draft guidance entitled “E8(R1) General Considerations for Clinical Studies.” The International Council for Harmonization document describes internationally accepted principles and practices for the design and conduct of clinical studies of drug and biologic products. In addition, it provides an overview of the types of
Drugs
FDA and HHS have published a Safe Importation Action Plan outlining two potential pathways to lay the foundation for the safe importation of certain drugs originally intended for foreign markets. An HHS statement says the plan outlines the pathways the Trump administration “intends to explore to allow safe importation of
Drugs
FDA has released the FDA-483 issued following a 7/15-7/19 inspection at the Cipla Virgonagar, India, active pharmaceutical ingredient (API) manufacturing site. The inspection observations were: * inadequate investigations into out-of-specification QC analytical results, related to finished API product quality failures; * failing to adequately design, install,
Drugs
FDA has approved a Bayer NDA for Nubeqa (darolutamide), an androgen receptor inhibitor for treating patients with non-metastatic castration-resistant prostate cancer. Approval is based on data from the Phase 3 ARAMIS trial evaluating Nubeqa plus androgen deprivation therapy (ADT), which demonstrated a significant improvement in the primary efficacy
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Information to Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements” (OMB Control Number 0910-0661). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing; Forms FDA 3486 and 3486A” (OMB Control Number 0910-0458). FDA requires a manufacturer who holds the
Drugs
FDA has released the FDA-483 issued following a 7/8-7/12 inspection at the Dr. Reddy’s Laboratories Unit 2 active pharmaceutical ingredient (API) manufacturing facility in Andhra Pradesh, India. The inspection observations were: * investigations into product complaints and out-of-specification quality control analytical results, related to
Devices
FDA has cleared a PhysIQ 510(k) for use of the company’s algorithm to continuously determine respiration rate in ambulatory patients. The clearance adds to PhysIQ’s current portfolio of FDA-cleared cloud-based analytics, which also include heart rate, heart rate variability, atrial fibrillation detection, and a personalized
Drugs
FDA and the European Medicines Agency have published a report on their 11/26/18 workshop with stakeholders on support for quality development in early access approaches such as PRIME (priority medicines) and Breakthrough Therapy designation. “Experience to date has shown that applicants face challenges to complete quality and manufacturing
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Medical Devices: Current Good Manufacturing Practice Quality System Regulation — 21 CFR Part 820” (OMB Control Number 0910-0073). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Unique Device Identification (UDI) System — 21 CFR Parts 16, 801, 803, 806, 810, 814, 820, 821, 822, and 830” (OMB Control Number 0910-0720). Medical device labelers, unless excepted, are required to design and use medical device
Drugs
FDA has published a draft guidance, General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products, to assist sponsors of NDAs, BLAs, and supplements who plan to conduct clinical studies in neonatal populations. The document says the guidance supplements a 2014 draft guidance on general clinical pharmacological considerations
Drugs
In a case involving a patent dispute between two drug companies, Washington Legal Foundation (WLF) has asked the 1st Circuit Court of Appeals to limit those who have standing to sue for damages for alleged antitrust violations. The WLF amicus brief says antitrust standing should be limited to those who
Drugs
HHS secretary Alex Azar told CNBC 7/30 that President Donald Trump is working on a proposal to allow the U.S. to import drugs from Canada. “I just got off the phone with him,” Azar said, “working on a plan on how we can import drugs safely and effectively
FDA Policy/General
Federal Register notice: FDA has announced medical device user fee rates and payment procedures for fiscal year 2020. They include PMA fee ($340,995), panel track supplement ($255,747), de novo classification request ($102,299), 180-day supplements ($51,149), real-time supplements ($23,870), 510(k) fee ($11,594)
FDA Policy/General
Federal Register notice: FDA has made available a revised draft guidance entitled “Rare Pediatric Disease Priority Review Vouchers.” The revision provides information on the rare pediatric disease priority review voucher program under which FDA will award priority review vouchers to sponsors of certain rare pediatric disease product applications that meet
Devices
FDA has cleared a Solio 510(k) for its Alfa Plus, intended for use in relieving chronic pain in addition to pain from trauma, sports injury and menstruation. The radio frequency (RF) device is designed for home use and uses a combination of RF, infrared technologies and low-level laser
Drugs
A 12/11/18-1/2/19 FDA inspection at the Scientific Solutions Global drug manufacturing facility, Carle Place, NY, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and other issues. A just-released 6/28 Warning Letter says specific violations were: * failing to have,
Drugs
California attorney general Xavier Becerra says he has reached four settlement agreements with drug companies who entered into “pay-for-delay” agreements to delay lower-priced prescription drugs from entering the market. The settlements will result in the companies making payments of nearly $70 million to the state, he says.
Drugs
Public Citizen says the Federal Trade Commission should block the proposed merger of Pfizer’s Upjohn unit with Mylan because it is anti-consumer. The consumer advocacy group says the proposal “would merge two notorious price gouging and allegedly price fixing firms into a generics behemoth that swallows product lines