Drugs
FDA has approved Mylan’s Ogivri (trastuzumab-dkst), the first biosimilar to Genentech’s Herceptin, indicated for treating patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors over-express the HER2 gene. Ogivri is the first biosimilar approved in the U.S. for breast or
Drugs
Health Research Laboratories and its owner, Kramer Duhon, have agreed to settle charges brought by the Federal Trade Commission (FTC) and the state of Maine that they deceived consumers with promises that their marketed dietary supplements could treat everything from arthritis to memory loss. A proposed federal court order bars
FDA Policy/General
Federal Register notice: FDA has announced a 1/11/2018 Antimicrobial Drugs Advisory Committee meeting. Panel members are expected to discuss an Aradigm Corp. NDA for ciprofloxacin dispersion for inhalation, indicated for treating non-cystic fibrosis bronchiectasis patients with chronic lung infections with Pseudomonas aeruginosa. To view the notice, click
FDA Policy/General
Federal Register notice: FDA has determined that Schering’s Meticorten (prednisone) tablets were not withdrawn from sale for reasons of safety or effectiveness. The determination will allow the agency to continue to approve ANDAs that reference the product as long as relevant legal and regulatory requirements are met. The action
Drugs
FDA has accepted for review a Lannett 505(b)(2) NDA for Numbrino (cocaine hydrochloride) topical solution, 4% and 10%, indicated for use as a local topical anesthetic. FDA has assigned a user fee review action target date of 7/21/2018. The submission is based on data from two
FDA Policy/General
Federal Register notice: FDA has announced the withdrawal of 68 ANDAs from multiple applicants. The application holders have notified the agency that the drug products are no longer marketed and requested that the approvals be withdrawn. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced its intent to exempt certain subtypes of surgical apparel from premarket notification requirements, subject to conditions and limitations. FDA intends to limit the proposed exemption to single-use, disposable respiratory protective devices used in a healthcare setting and worn by healthcare personnel during procedures
Drugs
A federal judge has sentenced a Corpus Christi, TX, man to 12 months in prison for selling online and in stores dietary supplements that contained misbranded or unapproved foreign drugs. Elias Trevino Jr. had earlier pleaded guilty to the charges, a government release says. At the time of his guilty
Drugs
The Center for Responsible Science (CRS) is suing FDA in DC federal court to force the agency to grant a CRS 6/2014 citizen petition on improved protections for human subjects in clinical trials. The petition asked that “FDA ensure every prospective trial participant receives the information necessary to evaluate
Drugs
Paragon Consulting says that FDA is delaying implementation of its 2013 Quality Metrics Initiative that will ultimately drive significant change in the way life sciences companies monitor and evaluate operational and quality performance. In an online report, Paragon says that as a result of refinements to two draft guidances and
Devices
A CDRH 11/21 webinar described two guidances relating to the de novo program. A final guidance, De Novo Classification Process (Evaluation of Automatic Class III Designation, provides updated recommendations for interacting with FDA, including what information to submit when seeking a path to market via the de novo classification
Drugs
FDA commissioner Scott Gottlieb assured Congress 11/30 that the timely implementation of the 21st Century Cures Act is one of the agency’s highest priorities. During a House Energy and Commerce Committee hearing on the status of the Cures Act almost one year after its enactment, Gottlieb said the
Drugs
A Pharmaceutical Research and Manufacturers of America (PhRMA) report tracing how money flows through the biopharmaceutical supply chain says that patients should benefit from cost payments that are negotiated at various points in the chain. “Drug pricing is a complex and often confusing issue, shaped by a pharmaceutical distribution and
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments (CLIA) Waiver by Application Studies.” It describes study designs for generating data that supports both 510(k) clearance and CLIA-waived categorization. Use of the Dual 510(k) and
FDA Policy/General
Federal Register notice: FDA has announced a 1/26/2018 public hearing on its approach to evaluating the safety and efficacy of nicotine replacement therapy products, including how they should be used and labeled. The hearing is intended to obtain input on the appropriate study designs and methods for evaluating
Devices
A 11/17 CDRH webinar provided an update on the Center’s digital health precertification pilot program. The agency says it wants to be transparent throughout the pilot process and will provide regular updates. At this point, it says, meetings have been held with all nine pilot participants to discuss
Drugs
FDA has approved an Advanced Bionics PMA supplement to add an acoustic earhook for its Naída CI Q90 sound processor that transforms the device into a cochlear implant and hearing aid combination. The addition is designed to provide cochlear implant recipients with natural low-frequency hearing, according to the company.
Drugs
New York University journalism professor Charles Seife says that it’s impossible to trust FDA decisions and statements because it “worries more about a drug’s side effect on a company than on a patient.” Writing in a lengthy Scientific American online article, Seife discusses agency efforts to withhold information
FDA Policy/General
Federal Register notice: FDA has determined that the regulatory review period for patent extension purposes for Wellstat Therapeutics’ Xuriden (uridine triacetate), indicated for treating hereditary orotic aciduria, is 8,494 days. Of this, 8,254 days occurred during the testing phase and 240 days occurred during the approval phase. To
Drugs
Merck KGaA and Pfizer have reported that the Phase 3 JAVELIN gastric cancer trial did not meet its primary endpoint of superior overall survival with avelumab compared with physician’s choice of chemotherapy. The trial investigated avelumab as a third-line treatment for unresectable, recurrent or metastatic gastric or gastroesophageal
FDA Policy/General
Federal Register notice: FDA has determined that the regulatory review period for patent extension purposes for Relypsa’s Veltassa (patiromer sorbitex calcium), indicated for treating hyperkalemia, is 2,844 days. Of this, 2,478 days occurred during the testing phase and 366 days occurred during the approval phase. To view
Devices
A 11/16 FDA webinar explained requirements in two recent final guidances on when to submit a 510(k) for a change to an existing device and when to submit a 510(k) for a software change to an existing device. During the program, CDRH acting associate director for regulations