Drugs
CDER has issued a Manual of Policies and Procedures (MAPP) outlining the process CDER review staff follows when (1) selecting or creating an established pharmacologic class text phrase that will be associated with an approved indication and included under the Indications and Usage section of labeling; and (2) assigning clinically
Drugs
Agile Therapeutics says it will appeal to the CDER Office of New Drugs the decision by the Office of Drug Evaluation 3 (ODE3) director to deny its appeal of a Division of Bone, Reproductive, and Urologic Products complete response letter for its NDA for Twirla (levonorgestrel/ethinyl/estradiol transdermal system)
Devices
FDA has approved an Endomagnetics Inc. PMA for the Magtrace and Sentimag Magnetic Localization System, a device for guiding lymph node biopsies in patients with breast cancer undergoing mastectomy. The device uses magnetic detection during sentinel lymph node biopsy procedures to identify specific (sentinel) lymph nodes for surgical removal, an
Drugs
FDA commissioner Scott Gottlieb says more focus is being placed on modernizing clinical trials. Testifying at a House Energy and Commerce Subcommittee hearing 7/25, Gottlieb said that the use of surrogate endpoints is getting much attention. He said that the agency had just released a list of biomarkers that
Devices
FDA has cleared a PerkinElmer 510(k) for its EuroImmun ANCA IFA and Europlus Granulocyte Mosaic assays and their use with the EuroPattern microscope. The assays are designed as indirect immunofluorescence tests for the qualitative or semi-quantitative determination of anti-neutrophil cytoplasmic antibodies ANCAof immunoglobulin class IgG in human
FDA Policy/General
Federal Register notice: FDA has announced a 9/4 public hearing on its approach to enhancing competition and innovation in the biological products marketplace, including greater availability of biosimilar and interchangeable products. The agency is interested in feedback on the following topics, among others: * Provide additional scientific or regulatory clarity
Drugs
FDA has placed a clinical hold on a Sarepta Therapeutics Phase 1/2 Duchenne muscular dystrophy micro-dystrophin gene therapy trial due to the presence of a trace amount of DNA fragment in research-grade third-party supplied plasmid. “Preliminary in-vivo testing performed by the research institute indicates that
Devices
FDA says Ycellbio Medical Co., Seoul, South Korea, is selling its Y-PRP System (Ycellbio kit) without an approved PMA or IDE in place. A 7/10 Notice of Violation says that promotional materials claim that the kit “facilitates separating and harvesting ‘pure sources of concentrated platelets’” from “a small
Devices
FDA is reminding hearing aid manufacturers that until the effective date of a published final regulation, there are no products that can legally claim to be over-the-counter hearing aids within the definition included in section 709 of the FDA Reauthorization Act of 2017. An agency letter to manufacturers
FDA Policy/General
Federal Register notice: FDA has announced a 9/12 Pharmacy Compounding Advisory Committee meeting. Panel members will receive information on balancing the criteria for 503A bulk drug substance evaluation and compounding as it relates to dietary supplements. In addition, the committee will discuss six bulk drug substances nominated for inclusion
FDA Policy/General
Federal Register notice: FDA has announced an 8/21 public workshop entitled “Regulatory Perspectives on Otic and Vestibular Toxicity: Challenges in Translating Animal Studies to Human Risk Assessment.” The workshop is intended to identify the challenges involved in the translation of toxicities from animal studies to clinical trials, to highlight
Drugs
Four drug companies have submitted their answers to an FDA docket seeking input to assist with development of a policy or guidance document on assessment of pH-dependent absorption and potential drug-drug interactions (DDI) with pH modulating agents such as proton-pump inhibitors (PPIs) or acid reducing agents (ARAs)
Drugs
Rep. John Sarbanes (D-MD) has introduced the Biosimilars Competition Act of 2018 to require biologic and biosimilar drug manufacturers to report anticompetitive “pay-for-delay” agreements that keep lower-cost drugs off the market. “We must take every step possible to prevent Big Pharma from continuing to raise drug
Devices
FDA has granted Med-El USA de novo marketing for its Bonebridge bone conduction hearing implant system for individuals 12 years and older who have been diagnosed with conductive hearing loss, mixed hearing loss, or single-sided deafness. The device comprises an internal BCI 601 implant, and a Samba audio
Drugs
Pharmaceutical Manufacturing Research Services (PMRS) is asking FDA not to approve any pending or future application for a section 505(b) or 505(j) opioid product with a proposed indication or any other labeling that suggests that the product is appropriate for chronic use. PMRS asks that its requests be
FDA Policy/General
FDA is launching a new public campaign focused on “recruiting skilled and dedicated employees who want to help FDA advance its public health mission.” The campaign includes print ads at rail stations, in rail cars, and on buses in the D.C. area. The campaign uses a new graphic and
FDA Policy/General
FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below: Lee Silsby Compounding Pharmacy Cleveland Heights, OH (7/10): FDA inspected the firm 6/2017 and found that it was not adhering
Drugs
FDA has approved an AbbVie NDA for Orilissa (elagolix), the first oral gonadotropin-releasing hormone (GnRH) antagonist specifically developed for women with moderate to severe endometriosis pain. Approval is supported by data from two replicate Phase 3 studies involving nearly 1,700 women with moderate to severe endometriosis pain. Clinical
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development.” The document describes the agency’s current recommendations on this subject where dietary management is a key component
Drugs
FDA has published a draft guidance, Use of Liquids and/or Soft Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality Assessments, addressing the approaches recommended for suitability determination of vehicles intended for use with specific drug products. The document provides: * consideration
Drugs
On the same day Public Citizen filed a lawsuit against it, FDA 7/23 partially granted the activist group’s objective: a ban on cesium chloride use in drug compounding sought in a 12/2017 petition. The group’s lawsuit was in response to the agency’s inaction on the
Drugs
FDA has released a draft guidance on “Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development.” The document describes the current recommendations about how to optimize and standardize dietary management in such trials where dietary management is a