FDA Policy/General
Draft Guide on Drug Master Files Federal Register notice: FDA makes available a draft guidance entitled “Drug Master Files.” 10/18/2019 10 Info Collections Approved by OMB Federal Register notice: FDA is publishing a list of information collections that have been recently approved by OMB. 10/18/2019 FDA/
Drugs
BIOLOGICS CSL Behring has received FDA approval of Idelvion [Coagulation Factor IX (Recombinant), Albumin Fusion Protein], its novel, long-acting albumin fusion protein linking recombinant coagulation factor IX with recombinant albumin for treating hemophilia B. The company says Idelivion is the first factor IX therapy that delivers high-level protection
Devices
FDA has cleared an Ortho Clinical Diagnostics 510(k) for the ORTHO Sera, a series of extended antigen phenotyping for use on the Ortho Vision Analyzer. The device’s extended phenotype testing covers more than 99% of the most commonly tested blood group antigens to support for patients with unexpected
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Drug Master Files.” The document provides FDA’s current thinking on submissions that may be used to provide confidential, detailed information about facilities, processes, or articles used in drug product manufacturing, processing, packaging, and storing. of human drug products.
FDA Policy/General
Federal Register notice: FDA is publishing a list of information collections that have been recently approved by OMB. They are: 1. Export of Medical Devices; Foreign Letters of Approval 2. Registration of Food Facilities 3. Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of
Drugs
American Gene Technologies (AGT) has submitted an IND for its lead HIV program, AGT103-T, a single-dose, lentiviral vector-based gene therapy being developed for eliminating HIV from people infected with the disease. The genetically-modified cell product is made from a person's own cells, and it
Drugs
FDA says Johnson & Johnson has recalled one lot of its Johnson’s Baby Powder (Lot #22318RB) after an agency sample detected chrysotile fibers, a type of asbestos. The sampling is part of FDA’s ongoing survey of cosmetic products for asbestos, which started in 2018. The agency says it
Devices
Nuvectra has submitted FDA-requested data to allow the agency to complete its review of a 2017-submitted PMA for Virtis, a sacral nerve stimulation (SNS) system for treating chronic urinary retention and overactive bladder symptoms. The company recently submitted supplementary chemical composition and biocompatibility data. The company says that
Drugs
FDA has approved a Teligent ANDA for Gentamicin Sulfate Cream USP, 0.1%. The drug is used to treat minor skin infections (such as impetigo, folliculitis) or minor infections related to some skin conditions (such as eczema, psoriasis, minor burns/cuts/wounds). The company says the annual sales for the
Devices
AdvaMed has written to President Donald Trump asking him to support permanent elimination of the medical device excise tax as part of a proposed 2020 tax package. “The medical device excise tax is set to return on New Year’s Day 2020 — a $20 billion tax increase on the dynamic
Drugs
Federal Register notice: FDA has announced it is accepting invitations to participate in the Fiscal Year 2020 CDER Office of Pharmaceutical Quality (OPQ) Staff Experiential Learning Site Visit Program. Pharmaceutical companies interested in participating in this program should submit a site visit proposal to OPQ by 11/17. The program
FDA Policy/General
Federal Register notice: FDA announces an 11/4 regional public meeting entitled “Health Canada and U.S. Food and Drug Administration Joint Regional Consultation on the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).” The meeting is scheduled to solicit public input on the current
Devices
CDRH has published a list of 27 guidances it proposes to issue during Fiscal Year 2020. The list includes 12 A-list final guidances that are prioritized for FY 2020 publication; nine A-list draft guidances; four B-list final guidances to be issued as resources permit during FY 2020;
Drugs
The Federal Trade Commission (FTC) says Nature City, Boca Raton, FL, which markets two aloe vera-based supplements, has agreed to pay $537,500 to settle charges that it deceived consumers with false and unsupported claims that its TrueAloe and AloeCran were effective treatments for a range of conditions affecting
Drugs
FDA has posted an online information sheet strongly advising women against the use of cannabidiol (CBD), tetrahydrocannabinol (THC), and marijuana in any form during pregnancy or while breastfeeding. The sheet says there are many potential negative health effects from using marijuana and other products containing THC during pregnancy and while
Devices
Johnson & Johnson and its Ethicon subsidiary have agreed to pay $116.86 million to 41 states and the District of Columbia to resolve allegations that they violated state consumer protection laws by misrepresenting the safety and effectiveness of transvaginal surgical mesh devices and also failed to sufficiently disclose risks
Drugs
FDA has accepted for review a Foamix Pharmaceuticals NDA for FMX103 (minocycline topical foam 1.5%) topical foam for treating moderate-to-severe papulopustular rosacea in adults. The agency has set a user fee review action target date of 6/2/2020. The submission is supported by data from two
Drugs
FDA has approved a Genentech supplemental NDA for Xofluza (baloxavir marboxil) for treating acute, uncomplicated influenza in people 12 years of age and older who have been symptomatic for no more than 48 hours and who are at high risk of developing flu-related complications. Xofluza was approved a year
Drugs
Viatrexx Bio has recalled all products in 10 mL sterile injectable vials because they were manufactured in a manner that cannot guarantee their sterility. “Administration of a non-sterile product, intended to be sterile, may result in a site-specific or systemic infection, which in turn may cause hospitalization, significant
Drugs
FDA’s Antimicrobial Drugs Advisory Committee has voted 14 to 2 to recommend approval of a Shionogi NDA for cefiderocol injection for its proposed indication to treat complicated urinary tract infections (cUTI). Cefiderocol is a siderophore cephalosporin with shown activity against several gram-negative bacteria. Briefing materials released in advance
Drugs
Ipsen is asking FDA to require that any proposed generic form of its Somatuline Depot (lanreotide acetate) for subcutaneous injection be tested in vivo to assure that it is bioequivalent to the reference-listed drug (RLD). “Based on Ipsen’s many years of experience with the product,” the company petition
Devices
FDA has cleared a Fidmi Medical 510(k) for its low-profile enteral feeding device. The gastrostomy device has a replaceable inner tube which can be changed by patients without the need to re-enter the healthcare system for replacement procedures, the company says. The device is designed to eliminate