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FDA has published a draft guidance, General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products, to assist sponsors of NDAs, BLAs, and supplements who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 The document says the guidance supplements a 2014 draft guidance on general clinical pharmacological considerations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Federal Register notice: FDA has made available a revised draft guidance entitled “Rare Pediatric Disease Priority Review Vouchers.”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
FDA Policy/General
Federal Register notice: FDA has announced fiscal year 2020 rates for the establishment and re-inspection fees related to entities that compound human drugs and register as outsourcing facilities. They are: small business establishment fee ($5,599), non-small business establishment fee ($18,288), and inspection fee ($16,798) for
Drugs
CDER says that starting 8/19, pre-assigned NDA, IND, BLA, and DMF number requests can be submitted through the Center’s NextGen Portal. FDA made that option available for ANDAs in June, a notice says. The notice identifies benefits of submitting requests through the portal as ease of use,
Drugs
Bipartisan leaders of the House Energy and Commerce Committee are asking for an FDA briefing on (1) the potential threat to the U.S. heparin supply due to the outbreak of African swine fever in China and (2) any contingency plans in the event of a serious shortage. In a
Drugs
FDA has accepted for review a Sunovion Pharmaceuticals NDA for dasotraline, a novel dopamine and norepinephrine reuptake inhibitor for treating patients with moderate-to-severe binge eating disorder (BED). The agency has set a 5/14/2020 review action target date. The submission is based on data from two 12-
Devices
FDA has cleared 510(k)s for four previously cleared Zeus Scientific tests with new indications to aid in diagnosing Lyme disease. The tests represent the “first time that a test has been indicated to follow a new testing paradigm in which two tests called enzyme immunoassays (EIA) are run
FDA Policy/General
Federal Register notice: FDA is seeking comments on a new information collection entitled “Obtaining Information To Understand Challenges and Opportunities Encountered by Compounding Outsourcing Facilities.” The collection supports proposed research on operational barriers and opportunities related to the outsourcing facility market and business viability; knowledge and operational barriers and opportunities
FDA Policy/General
FDA has posted a final guidance entitled “Delayed Graft Function in Kidney Transplantation: Developing Drugs for Prevention.” The document addresses the agency’s current thinking regarding the overall development program and clinical trial designs for systemic drugs administered to the kidney transplant recipient to support an indication of preventing delayed
Drugs
FDA has granted Orchard Therapeutics a Regenerative Medicine Advanced Therapy designation for the company’s ex vivo autologous hematopoietic stem cell-based gene therapy (OTL-103) for treating Wiskott-Aldrich Syndrome (WAS). The designation was based on data from an interim analysis of a registrational trial in patients with severe
Drugs
FDA has posted a Form 483 after completing an inspection of First Pharma Associates in Spokane, WA last month. The inspection cited the firm for non-microbial contamination that was observed in the production area. FDA said its investigator observed personnel manually contacting the inner surface of containers and closures.
Devices
FDA has approved an Intersect Ent PMA for its Straight Delivery System for use in placing the company’s Propel Mini steroid-releasing implant in the ethmoid sinus. The company says Propel is intended to help maintain the sinus opening while delivering mometasone furoate directly where it is needed, improving
FDA Policy/General
Federal Register notice: FDA has determined that Andrx Labs’ Fortamet (metformin hydrochloride) extended-release tablets, 500 mg and 1 g, were not withdrawn from sale for safety or effectiveness reasons. The determination means that FDA can continue to approve ANDAs that refer to these products as long as they meet
Drugs
FDA has issued a revised draft guidance, Rare Pediatric Disease Priority Review Vouchers. The document incorporates public comments received on an initial draft and provides FDA’s thinking on the Advancing Hope Act of 2016 provisions, which updated the definition of a rare pediatrics disease as one that is both