Devices
FDA has approved a Medtronic PMA for its Intellis platform for managing certain types of chronic intractable pain. The implantable neurostimulator was designed for improved patient comfort and to overcome limitations with current spinal cord stimulation systems, such as battery performance, the company says. It can continuously record and track
FDA Policy/General
Federal Register notice: FDA is amending the animal drug regulations to reflect application-related actions for a NADA and ANADAs approved during March and April. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents. To view the notice,
FDA Policy/General
Rep. Erik Paulsen (R-MN) believes that reforming FDA is long overdue. Writing in a The Hill opinion piece, the congressman says the agency’s regulatory responsibilities have grown in recent decades and it is suffering from a “top-heavy bureaucracy and an increasingly outdated regulatory model. And, given its
FDA Policy/General
FDA has approved an Ipsen Biopharmaceuticals supplemental NDA for Somatuline Depot (lanreotide) Injection 120 mg for treating carcinoid syndrome. The company says that when used for this indication, the therapy reduces the frequency of short-acting somatostatin analog rescue therapy. Somatuline Depot is also approved for improving progression-free survival
Drugs
FDA has posted 10 annex guidance documents developed by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). The documents describe the evaluations and recommendations by the Q4B Expert Working Group of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as
Drugs
Sanofi and Regeneron Pharmaceuticals have announced positive results from the Phase 3 CAFÉ study of Dupixent (dupilumab) in adults with moderate-to-severe atopic dermatitis who are inadequately controlled with or intolerant to the broad immunosuppressant drug cyclosporine A, or when this treatment is medically inadvisable. In the study, according
Drugs
FDA has issued a seven-item Form 483 after inspecting U.S. Specialty Formulations last month. According to the just-posted document, the firm was cited for personnel gowning for aseptic operations in non-classified areas, and the gowning area is not supplied with HEPA-filtered air. The investigator also
Drugs
The U.S. government has stepped into an ongoing Biologics Price Competition and Innovation Act (BPCIA) dispute (Amgen v. Sandoz) involving biosimilar-related disclosure provisions. According to the U.S. amicus brief, the BPCIA “preempts any state-law remedies for an applicant’s decision not to make the disclosures identified
Drugs
FDA has approved CSL Behring’s Privigen [immune globulin intravenous (human), 10% liquid] for treating adults with chronic inflammatory demyelinating polyneuropathy to improve neuromuscular disability. The rare autoimmune disorder affects peripheral nerves and may cause permanent nerve damage. Approval was based on data from two Phase 3 clinical studies, PATH
Drugs
FDA has approved a Nesher Pharmaceuticals ANDA for the first generic version of Genentech’s Tamiflu (oseltamivir phosphate) for oral suspension, 6 mg (base)/mL, indicated for patients that are not able to ingest capsules for treating influenza A and B in those two weeks of age and older. The
Drugs
FDA has approved a UCB supplemental NDA for Briviact (brivaracetam) as monotherapy for partial-onset (focal) seizures (POS) in patients 16 years and older with epilepsy. Briviact is already approved in the U.S. as adjunctive treatment for POS in patients in this age group. It is in the “racetam”
Devices
T2 Biosystems has filed a 510(k) for the T2Bacteria Panel that is designed to run on the company’s T2Dx Instrument as a rapid diagnostic solution to identify pathogens associated with sepsis within hours instead of days, potentially enabling 95% of patients with bloodstream infections to receive targeted therapy
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance #210 entitled “The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species.” The document describes the process for adding a new animal drug to the index, which comprises legally marketed unapproved new animal drugs for minor species that
FDA Policy/General
Federal Register notice: FDA has made available the safety and effectiveness summaries of recent PMAs approved by CBER. Summaries available include Hologic’s Aptima HIV-1 Quant Assay and Roche Diagnostics’ Elecsys HIV Combi-PT. To view the notice, click here.
Devices
FDA does not want to be reactive as it approaches issues of cyber security, according to CDRH associate director for science and strategic partnerships Suzanne Schwartz, speaking 9/13 at the Healthcare Security Forum in Boston. She said the agency’s mission is “harnessing the collective will and creating a
Drugs
FDA says the International Conference on Harmonization (ICH) E18 guidance Guideline on Genomic Sampling and Management of Genomic Data, reached Step 4 of the ICH process this month and moves now to implementation. The document is intended to provide harmonized principles of genomic sampling and management of genomic data in
Devices
A New York federal court has dismissed a suit against Bayer over its Essure implantable birth control device, holding that the plaintiff failed to allege a violation of federal law that parallels state law claims of negligent misrepresentation, strict liability, failure to warn, and breaches of express and implied warranty.
Drugs
FDA has approved Amgen’s Mvasi (bevacizumab-awwb), a biosimilar to Genentech’s Avastin (bevacizumab), for treating multiple types of cancer. It is the first biosimilar approved in the U.S. to treat cancer. An agency news release says Mvasi is approved to treat adult patients with certain colorectal, lung,
Devices
FDA has issued a guidance, Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses, to facilitate study designs to establish the performance characteristics of in vitro diagnostic devices intended for the detection or detection and differentiation of human papillomaviruses. The
Drugs
FDA has approved AstraZeneca’s asthma therapy Symbicort (budesonide/formoterol fumarate dihydrate) inhalation aerosol 160/4.5 micrograms to reduce exacerbations of chronic obstructive pulmonary disease (COPD). Expanded approval was based on data from two Phase 3 studies of six-month (Trial 3 — The RISE Study) and 12-month (Trial
Drugs
FDA has permitted under its de novo process the marketing of the first mobile medical application to help treat substance use disorders (SUDs). Pear Therapeutics Reset application is intended to be used with outpatient therapy to treat alcohol, cocaine, marijuana and stimulant SUDs, according to an agency notice. The mobile
Devices
FDA has issued a draft guidance, Regulatory Considerations for Microneedling Devices, to assist industry in understanding when a microneedling product is defined as a medical device and thus subject to device requirements under the law and regulations. The document also provides clarity on the regulatory pathway to market for microneedling