Drugs
FDA says it is asking manufacturers of ranitidine (Zantac) and nizatidine (Axid) to expand their testing for N-nitrosodimethylamine (NDMA) in all lots of the medications before making them available to consumers. An agency statement says that if testing shows NDMA above the acceptable daily limit of 96 nanograms/day
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision for “Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements — 21 CFR Part 111” (OMB Control Number 0910-0606). FDA regulations in 21 CFR Part 111 establish minimum GMP requirements pertaining to the
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Human Cells, Tissues, and Cellular and Tissue-Based Products: Establishment Registration and Listing; Eligibility Determination for Donors; and Current Good Tissue Practice” (OMB Control Number 0910-0543). FDA regulations require domestic and foreign establishments that recover, process,
Drugs
ViiV Healthcare has submitted an NDA for fostemsavir, an investigational, first-in-class attachment inhibitor for treating HIV-1 infection. The drug is under development for combination use with other antiretroviral agents in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection who are unable to form a suppressive
FDA Policy/General
Federal Register notice: FDA is requesting that any industry organizations interested in participating in selecting nonvoting industry representatives to serve on certain Medical Devices Advisory Committee panels notify the agency in writing. It is also requesting nominations such representatives. To view the notice, click here.
Drugs
The CDRH Manufacturer and User Facility Device Experience (MAUDE) database does not make public information on the sex of patients involved in a medical device adverse event for reasons of “patient confidentiality.” However, the CDER FDA Adverse Events Reporting System (FAERS) makes such information publicly available. Because the International Consortium
Devices
FDA has authorized marketing of Roche Molecular Systems’ new diagnostic test based on bacterial viability and novel technology to detect methicillin-resistant Staphylococcus aureus (MRSA) bacterial colonization. An agency statement says the cobos vivoDX MRSA diagnostic test may allow healthcare professionals to evaluate patients for colonization with MRSA bacteria more
Biologics
The CBER Office of Compliance and Biologics Quality says Chara Biologics, Woodland Hills, CA, is marketing its unapproved CharaCore product to consumers, including parents of children with autism. According to an FDA letter to the company, the firm’s Web sites say that CharaCore contains “umbilical, cord tissue, and amniotic
Drugs
FDA has approved three ANDAs for the first generics of Novartis’ Gilenya (fingolimod) capsules for treating relapsing forms of multiple sclerosis in adult patients. Approvals were granted to HEC Pharm Co., Biocon Limited and Sun Pharmaceutical Industries. An FDA release says that fingolimod must be dispensed with a Medication Guide
Drugs
FDA has launched CURE ID, an Internet-based repository that will allow the clinical community to report their experiences treating difficult-to-treat infectious diseases with novel uses of existing FDA-approved drugs through a Web site, smart phone, or other mobile device. An agency statement says the platform “enables
Drugs
Genus Lifesciences says FDA applied a different and much more lenient standard to an application submitted by Lannett for its cocaine hydrochloride product that Genus says is substantially similar to its Goprelto product. In an 11/27 letter, Genus says that FDA required it to submit results from several studies
Devices
The Obesity Action Coalition and American Society for Metabolic and Bariatric Surgery say an FDA discussion paper on benefit/risk approaches for weight loss medical devices may not recognize that treating the chronic disease of obesity requires a full continuum of care. The groups’ comment letter says that discussion paper
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS): Establishing Effectiveness of Drugs for Treatment.” The document provides FDA’s recommendations for clinical trials intended to establish clinical effectiveness and safety for such drugs. To view the notice, click here.
Devices
FDA has cleared an EmCyte 510(k) for its Progenikine Concentrating System for adipose lipoplasty. The company says the device is cleared for all medical procedures involving the harvesting and transferring of autologous adipose tissue. It is designed for pure extraction and centrifugal preparation of adipose concentrate at the point
Drugs
FDA has published a draft guidance, Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS): Establishing Effectiveness of Drugs for Treatment, with recommendations for establishing effectiveness for drugs intended to treat patients with interstitial cystitis/bladder pain syndrome. The document incorporates recommendations the agency received at a 12/2017 advisory committee meeting
FDA Policy/General
Federal Register notice: FDA has established a docket to obtain information and comments that will assist it in determining whether to establish a pilot program for the toxicological and quality evaluation of novel excipients intended for use in human drugs. Historically, FDA has not reviewed the safety of novel excipients
Devices
A recent CDRH Industry Basics Webcast covered Webpage and multimedia resources available for industry on a variety of CDRH topics and then gave basic information on the 513(g) request for information process and the custom device exemption process. In the show’s first hour, CDRHer Ifearyi Uwemedimo discussed how
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Spark Therapeutics Luxturna (voretigene neparvovec-rzyl), indicated for treating patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy. The review period is 3,809 days, which includes 3,591 days that occurred during the testing
Devices
A nonpartisan Tax Foundation report issued by AdvaMed says that if the medical device tax continues due to congressional inaction, there will be a loss of 21,390 U.S. medical technology jobs in the next two years and a $1.74 billion decline in the nation’s gross national
FDA Policy/General
The Medical Information Working Group (MIWG) says FDA should include recent Supreme Court First Amendment free speech decisions in its ongoing analysis of manufacturer communications regarding unapproved uses of approved or cleared medical products. In a comment to the agency docket on the subject, MIWG says FDA should ensure that
FDA Policy/General
Federal Register notice: FDA has announced a 12/17 Oncologic Drugs Advisory Committee meeting. During the morning session, the committee will discuss an AstraZeneca supplemental NDA for Lynparza (olaparib) tablets, indicated for maintenance treatment of adult patients with deleterious or suspected deleterious gBRCAm metastatic adenocarcinoma of the pancreas whose disease
Drugs
The Justice Department says a deferred prosecution agreement reached with Rising Pharmaceuticals, a New Jersey generic drug company, will resolve charges through the company’s admission that it conspired with a competing generic drug company to fix prices and allocate customers for benazepril HCTZ. A one-count felony charge filed