Devices
FDA has expanded the approved use of GlaxoSmithKline’s Nucala (mepolizumab) to treat adult patients with eosinophilic granulomatosis with polyangiitis (EGPA), a rare autoimmune disease that causes vasculitis. Formerly, EGPA was known as Churg-Strauss syndrome, a condition characterized by asthma, high levels of eosinophils (a type of white blood
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Orphan Products Development; FDA Orphan Drug Designation Request Form and The Common European Medicines Agency/FDA Form for Orphan Medicinal Product Designation (Formerly Orphan Drugs; Common European Medicines Agency/FDA Application Form for Orphan Medicinal Product Designation
Devices
CDRH says it is actively working to increase appropriate use and improve the impact of PROs (patient-reported outcomes) as evidence in regulatory decisions and beyond. The Center makes the commitment in a strategic priority document — Value and Use of Patient-Reported Outcomes (PROs) in Assessing Effects of Medical Devices.
Devices
AdvaMed says FDA’s voluntary medical device manufacturing and product quality program (appraisal program) reflects “the agency’s use of innovative strategies to collaborate with stakeholders to improve medical device design and manufacturing quality and, by extension, public health outcomes…. AdvaMed supports the appraisal program and hopes it will succeed
FDA Policy/General
Federal Register notice: FDA has announced the Web site location where it will post two lists of guidance documents that CDRH intends to publish in fiscal year 2018. In addition, the agency has established a docket for accepting comments on priority topics for guidance, proposing draft language for those topics,
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisements” that clarifies the requirements for product name placement and prominence in ads. To view the notice, click here.
Drugs
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Fagron Compounding Services Wichita, KS (11/28): FDA inspected the outsourcing drug facility in 2016 and cited serious deficiencies in its practices for producing sterile drug products. For example,
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “FDA Application for Participation in FDA Fellowship Programs” (Formerly Application for Participation in the FDA Commissioner’s Fellowship Program) — OMB Control Number 0910–0780. The information collection involves brief online applications completed by applicants applying to FDA’
Drugs
FDA has posted a final guidance on “Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisements.” The document clarifies the agency’s requirements and addresses circumstances under which FDA intends to not take enforcement action in such matters. The guidance recommends that the established name be placed directly
Drugs
Janssen Research & Development has submitted a supplemental NDA for two new Xarelto (rivaroxaban) vascular indications: reducing the risk of major cardiovascular (CV) events such as CV death, heart attack or stroke in patients with chronic coronary or peripheral artery disease (CAD/PAD), and for reducing the risk of acute
Devices
Early next year, FDA says it will publish a draft guidance outlining a voluntary, alternative pathway for demonstrating substantial equivalence to meet 510(k) criteria for certain devices. “This pathway will allow more flexibility to use more modern criteria as the reference standard, and permit comparisons to standards that more
Drugs
FDA has approved Sanofi-Aventis’ Admelog (insulin lispro injection), a short-acting insulin indicated to improve control in blood sugar levels in adults and pediatric patients aged three years and older with Type 1 diabetes mellitus and adults with Type 2 diabetes mellitus. FDA says that Admelog is the first
Drugs
CDER’s Office of Testing and Research is conducting research to better understand 3D or additive manufacturing’s use in making drug products. “3D printing can offer a tantalizing step toward changing the manufacturing processes to offer personalized medicines,” a new blog post says. “For example, we are working to
Devices
FDA has approved an Intersect ENT PMA for the Sinuva (mometasone furoate) Sinus Implant, a new targeted approach to treating recurrent nasal polyp disease in patients who have had previous ethmoid sinus surgery. Inserted during a routine physician office visit, Sinuva expands into the sinus cavity and delivers an anti-
Drugs
Workshop on Software Precertification Program Federal Register notice: FDA announces a 1/30-31/2018 public workshop entitled “Fostering Digital Health Innovation: Developing the Software Precertification Program.” 12/08/2017 Comments Sought on Oncology Center of Excellence Functions Federal Register notice: FDA announces a 3/15/2018 public meeting entitled
Drugs
DEVICES FDA has approved Foundation Medicine’s FoundationOne CDx (F1CDx), the first breakthrough-designated, next generation sequencing-based in vitro diagnostic test that can detect genetic mutations in 324 genes and two genomic signatures in any solid tumor type. An agency news release says that compared to other companion diagnostics
FDA Policy/General
Federal Register notice: FDA has announced a 1/30-31/2018 public workshop entitled “Fostering Digital Health Innovation: Developing the Software Precertification Program.” The workshop is intended to discuss the progress of the agency’s pilot precertification program and to seek input on the program’s ongoing development. The program
FDA Policy/General
Federal Register notice: FDA has announced a 3/15/2018 public meeting entitled “Oncology Center of Excellence (OCE): Listening Session” that is intended for stakeholders to provide input on the Center’s functions. Specifically, the agency seeks comments on OCE’s structure, function, regulatory purview, and activity. To view the
Drugs
Mylan has petitioned FDA to require specific bioequivalence study designs for ANDA applicants seeking to market generic versions of GlaxoSmithKline’s asthma therapy Advair Diskus (fluticasone propionate and salmeterol xinafoate) inhalation powder. The Mylan petition asks FDA to refrain from approving any ANDA that “relies on multiple-batch pharmacokinetic (PK)
Drugs
Senator Elizabeth Warren (D-MA) has introduced the National Biomedical Research Act that would increase funding for targeted biomedical research initiatives through a new, reliable funding stream supporting both NIH and FDA. The bill would provide $5 billion annually in supplemental funding for grants for young emerging scientists, and breakthrough
FDA Policy/General
Federal Register notice: FDA is seeking comments on a statement of work to assess current practices when communicating during IND development and identify best practices and areas of improvement. The independent assessment is part of the agency’s user fee performance commitments. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has released its annual report on the status of drug/biologic postmarketing requirements and postmarketing commitments on studies and clinical trials that applicants have agreed to, or are required to, conduct. To view the notice, click here.