Devices
FDA has approved an expanded indication for the Concentric Medical Trevo clot retrieval device to allow treatment of certain stroke patients up to 24 hours after symptom onset, expanding the use to a broader group of patients. An agency news release says the device is cleared for use as an
Devices
FDA has authorized marketing of the Banyan Biomarkers Banyan Brain Trauma Indicator, a blood test used to evaluate mild traumatic brain injury (concussion). An agency news release says that most patients with a suspected head injury are examined using a neurological scale (Glasgow Coma Scale) followed by a CT head
Drugs
FDA has accepted for review an Agios Pharmaceuticals NDA for ivosidenib (AG-120) for treating patients with relapsed or refractory acute myeloid leukemia with an isocitrate dehydrogenase 1 mutation. The submission was granted a priority review, with a user fee review action date of 8/21. Ivosidenib is a first-
Devices
FDA has granted Abiomed expanded PMA approval for the Impella 2.5 and Impella CP heart pumps and their use during elective and urgent high risk percutaneous coronary intervention procedures. The approval also eliminates an earlier requirement for depressed ejection fraction in the presence of severe coronary artery disease or
Drugs
Apace Packaging has recalled one lot of shingles therapy acyclovir tablets, USP, 400mg, (NDC# 50268-061-15, lot number 19900) due to a product mix-up. A small number of blister cards containing acyclovir tablets, 400mg, may potentially also include torsemide, 20mg, tablets. “Missing a dose of acyclovir tablets could
FDA Policy/General
Federal Register proposed rule: FDA is proposing to amend its postmarketing safety reporting regulations for approved new animal drugs to require that certain adverse drug experience and product/manufacturing defect reports be submitted in an electronic format. The proposed change would allow FDA to more rapidly review such reports, identify
Drugs
FDA says its 2/7 approval of an ANDA for trientine hydrochloride (Valeant’s Syprine) to treat Wilson disease renders moot an 8/17/17 petition requesting such an approval. The agency response says the petition “asserted that the approval of an ANDA for trientine hydrochloride will make available a
Drugs
Pharmaceutical industry stakeholders are telling FDA about many regulations they believe could be eliminated or modified in the interest of reducing administrative burden and improving efficiency. In a 127-page response, Pharmaceutical Research and Manufacturers of America lists 41 topics under three overriding categories — manufacturer communications and prescription drug labeling,
Drugs
FDA has issued a guidance, Regulatory Classification of Pharmaceutical Co-Crystals, to give applicants planning to submit NDAs and ANDAs information on the appropriate regulatory classification of pharmaceutical co-crystal forms. The guidance includes information about the data that applicants should submit to support the appropriate classification of a co-
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it believes an FDA draft guidance on refusal to file NDA and BLA submissions to CDER will help manufacturers prepare complete applications that are ready for filing, reducing burdens on industry and the agency both. But it also says that some aspects
FDA Policy/General
Federal Register notice: FDA has announced a 3/19 workshop on “Utilizing Innovative Statistical Methods and Trial Designs in Rare Disease Settings.” The workshop’s goal is to discuss with stakeholders the development and regulatory decision-making challenges for such products. It will also address promising study designs and analytical
FDA Policy/General
FDA principal deputy commissioner Rachel Sherman says the agency doesn’t do well at developing experienced successors to key leaders who are approaching retirement. “It’s not our strongest suit, to be perfectly honest,” she said at the BIO CEO & Investor Conference 2/13. “We’re getting old,” Sherman
Drugs
FDA has approved a Janssen Pharmaceutical NDA for Erleada (apalutamide) for treating patients with prostate cancer that has not spread, but that continues to grow despite treatment with hormone therapy (castration-resistant). An agency release says that this is the first approved treatment for non-metastatic, castration-resistant prostate cancer.
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes that the regulatory review period for Warner-Lambert’s Ibrance (palbociclib) is 3,954 days. Of this time, 3,779 days occurred during the testing phase and 175 days during the approval phase. Ibrance is indicated for treating of hormone
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes that the regulatory review period for Boehringer Ingelheim’s Jardiance (empagliflozin) is 2,275 days. Of this time, 1,760 days occurred during the testing phase and 515 days during the approval phase. Jardiance is indicated as an adjunct to
Drugs
Merck says it is ending its APECS Phase 3 study evaluating verubecesat, an investigational small molecule inhibitor of the beta-site amyloid precursor protein cleaving enzyme, in people with prodromal Alzheimer’s disease. The company says its decision to end the study follows an external data monitoring committee evaluation that
Drugs
The National Institute of Allergy and Infectious Diseases says it is sponsoring a clinical trial to determine whether low blood levels of the protein procalcitonin (PCT) can reliably indicate whether a person’s lower respiratory tract infection will improve with antibiotic treatment. The agency says that healthcare providers often prescribe
Drugs
A 1/12-1/20/17 FDA inspection at the Bayer Pharma AG drug manufacturing facility in Leverkusen, Germany, found significant violations of current good manufacturing practice regulations for finished pharmaceuticals, according to a just-released 11/14/17 Warning Letter. Specific violations cited in the letter were: * failing to
Devices
A 5/6-5/11/17 FDA inspection at Curasan AG, Frankfurt, Germany, found Quality System and Medical Device Reporting violations in the firm’s manufacturing of Cerasorb Dental, Cerasorb M Dental, Cerasorb Perio, Revios Implant System, IngeniOs HA (Osborne Dental), IngeniOs Beta-TCP Bioactive (Ceracell Dental), and Cerasorb Ortho
FDA Policy/General
Federal Register notice: FDA has announced a 3/1 Vaccines and Related Biological Products Advisory Committee meeting. During the meeting, panel members will hear an overview of the research program in the Laboratory of Mucosal Pathogens and Cellular Immunology. They will also discuss and make recommendations on the selection of
FDA Policy/General
Federal Register notice: FDA has announced a 4/30 public workshop entitled “Orthopedic Sensing, Measuring, and Advanced Reporting Technology (SMART) Devices.’’ The workshop is intended engage with stakeholders to facilitate device development and to discuss scientific and regulatory challenges associated with Orthopedic SMART Devices. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has amended a notice about a 3/1 Neurological Devices Panel of the Medical Devices Advisory Committee meeting to reflect a change in the procedure portion of the document. It is now changed to read as follows: Procedure: FDA will work with affected industry organizations that