FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Taka USA, Carrollton, TX (7/29) FDA inspected the company 6/2019 and cited significant GMP violations for finished pharmaceuticals. For example, Taka failed to have for each batch
Devices
FDA has released updated information on the adverse event information from the first monthly spreadsheet Bayer is required to submit to the agency on its Essure birth control device. An agency notice (includes a link to the spreadsheet) says Bayer is required to submit the spreadsheets under a 4/24
Devices
FDA has approved a Guardant Health PMA for the Guardant360 CDx assay, the first liquid biopsy companion diagnostic that also uses next-generation sequencing technology to identify patients with specific types of mutations of the epidermal growth factor receptor (EGFR) gene in a deadly form of metastatic non-small cell
Devices
Becton Dickinson (BD) is predicting a six-month delay in submitting a 510(k) for modifications to its troubled Alaris infusion pump. On a recent earnings call, BD president Tom Polen told analysts that the 510(k) should be filed in late March of 2021, which is about six months
Drugs
Gilead Sciences has submitted an NDA for Veklury (remdesivir), indicated for treating patients with Covid-19. Remdesivir is currently available in the U.S. under an emergency use authorization for treating hospitalized patients with severe Covid-19. The submission is based on data from two Phase 3 clinical studies that
Drugs
FDA has approved a Trevena NDA for Olinvyk (oliceridine), an opioid agonist for managing moderate to severe acute pain in adults when the pain is severe enough to require an intravenous opioid and alternative treatments are inadequate. The drug is indicated for short-term intravenous use in hospitals or other
Drugs
FDA has made available a guidance entitled “Bioresearch Monitoring Technical Conformance Guide.” The document provides the agency’s current thinking on preparing and submitting clinical study-level information, subject-level data line listings by clinical site, and a summary-level clinical site dataset used by CDER for planning Bioresearch Monitoring
FDA Policy/General
Federal Register notice: FDA announces an 8/31 online Pulmonary-Allergy Drugs Advisory Committee meeting. Panel members are scheduled to a discuss a GlaxoSmithKline supplemental NDA for Trelegy Ellipta (fluticasone furoate, umeclidinium, and vilanterol inhalation powder oral inhalation), indicated for reducing all-cause mortality in patients with chronic obstructive pulmonary
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Drug-Drug Interaction Assessment for Therapeutic Proteins.” The document is intended to provide a systematic, risk-based approach to help sponsors determine the need for drug-drug interaction studies for a therapeutic protein. To view the notice, click here.
Drugs
FDA has made available a guidance entitled Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format. It advises NDA/ANDA holders to provide a written notification to FDA 180 days prior to withdrawing an approved drug from sale. It also asks them
Biologics
FDA has accepted for priority review a Biogen and Eisai BLA for aducanumab, an investigational treatment for Alzheimer’s disease. The agency has set a user fee review action date of 3/7/2021. If approved, aducanumab would be the first therapy for reducing Alzheimer’s “clinical decline,” according to
Drugs
FDA has made available a draft guidance entitled “Drug-Drug Interaction Assessment for Therapeutic Proteins.” The document is intended to help sponsors determine the need for drug-drug interaction (DDI) studies for a therapeutic protein by providing a systematic, risk-based approach. When evaluating the potential for a DDI, FDA
Drugs
FDA has approved Genentech’s Evrysdi (risdiplam) for treating spinal muscular atrophy (SMA) in adults and children two months of age and older. SMA is a rare and often fatal genetic disease affecting muscle strength and movement. The hereditary disease causes weakness and muscle wasting because patients lose lower motor
Devices
FDA has cleared a Joimax PMA for its Intracs, an electromagnetic navigation tracking and control system, which the company says allows spinal procedures to be carried out with minimal X-ray control. Joimax says all of the device's instruments and scopes can be tracked and navigated with sensors,
Drugs
California has reached a settlement agreement with AbbVie Inc. to resolve a lawsuit alleging violations of the California Insurance Frauds Prevention Act involving the marketing of Humira (adalimumab), indicated for treating arthritis, plaque psoriasis, ankylosing spondylitis, Crohn’s disease, and ulcerative colitis. “AbbVie agreed to reform its Humira marketing practices
Drugs
FDA has approved ViiV Healthcare’s Dovato (dolutegravir/lamivudine) as a complete regimen for treating HIV-1 infection to replace the current antiretroviral regimen in adults who are virologically suppressed on a stable regimen with no history of treatment failure and no known resistance to the individual components of Dovato.
Drugs
The FDA FY 2019 annual report on the status of postmarketing requirements (PMRs) and postmarketing commitments (PMCs) shows that the majority of the requirements and commitments were completed or are moving toward completion according to the original schedule. “Very few PMRs/PMCs are ‘delayed,’” the agency says in a statement
FDA Policy/General
Federal Register notice: FDA has made available an annual report entitled “Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments.” To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Limited Population Pathway for Antibacterial and Antifungal Drugs.’’ The document provides information on implementing the pathway which is a provision of the 21st Century Cures Act. To view the notice, click here.
Drugs
The Rare Disease Clinical Trial Network (RDCRN) funded by the National Institute of Health says there is a need for a Rare Disease Clinical Trial Resource Center that could be leveraged by existing research networks or consortia doing global clinical research in rare diseases. The recommendation is part of the
Drugs
FDA has granted GlaxoSmithKline accelerated approval for Blenrep (belantamab mafodotin-blmf) for adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent. Approval was based on data from the DREAMM-2,
Drugs
Ferring Pharmaceuticals has recalled all lots of DDAVP (desmopressin) nasal spray 10 mcg/0.1mL, desmopressin acetate nasal spray 10 mcg/0.1mL, and Stimate (desmopressin) nasal spray 1.5 mg/mL. The products are being recalled due to superpotency concerns, an out-of-specification result detected during routine testing.