Devices
FDA has granted Empirical Spine a breakthrough device designation for its LimiFlex Paraspinous Tension Band and its use in spinal surgery. Key potential benefits cited in the company’s breakthrough request include “shorter surgery, improved intra- and post-operative outcomes, reduction or elimination of hospitalization length of stay, and improved
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Ardelyx’s Ibsrela (tenapanor hydrochloride), indicated for treating irritable bowel syndrome with constipation in adults. The review period was determined to be 3,219 days, which includes 2,853 days that occurred during the testing
FDA Policy/General
Federal Register notice: FDA is amending the animal drug regulations to reflect application-related actions for new animal drug applications and abbreviated new animal drug applications during October, November, and December 2020. The agency is also informing the public about the availability of summaries of the basis of approval and
Biologics
FDA has permitted two Moderna Covid-19 revisions regarding the number of doses per vial available. “The first revision clarifies the number of doses per vial for the vials that are currently available, in that the maximum number of extractable doses is 11, with a range of 10-11 doses,
Devices
Allarity Therapeutics has submitted a PMA for DRP-Dovitinib, the company's validated companion diagnostic for Novartis’ dovitinib that is intended to be used to identify patients suffering from renal cell carcinoma. Allarity is licensing the drug from Novartis and plans to submit an NDA later this year. The
FDA Policy/General
FDA acting commissioner Janet Woodcock has identified five key activities the agency experienced during the Covid-19 pandemic that will be expanded or continued after the public health emergency has ended. “As we continue our Covid-19 response, it is critical that we learn from both our successes and the
Drugs
Bristol-Myers Squibb (BMS) has agreed to pay the U.S. Government and participating states a total of $75 million to resolve allegations that it knowingly underpaid rebates owed under the Medicaid Drug Rebate Program. The settlement resolves allegations that BMS underreported the “Average Manufacturer Prices (AMPs)” for a number
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Siga Technologies’ Tpoxx (tecovirimat monohydrate), indicated for treating human smallpox disease in adults and pediatric patients weighing at least 13kg. The review period was determined to be 4,601 days, which includes 4,383 days
FDA Policy/General
Federal Register notice: FDA has determined that Fougera Pharmaceuticals’ Cutivate (fluticasone propionate) ointment, 0.005%, was not withdrawn from sale for safety or effectiveness reasons. The determination will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
FDA Policy/General
Federal Register notice: FDA has determined that Novartis’ Serentil (mesoridazine besylate) tablets 10 mg, 25 mg, 50 mg, and 100 mg were not withdrawn from sale for safety or effectiveness reasons. Serentil is indicated for managing schizophrenic patients who fail to respond adequately to treatment with other antipsychotic drugs. The
Devices
FDA says it wants to be sure that healthcare providers, including those who work in healthcare facility reprocessing units, are aware of the risk of infections associated with reprocessed urological endoscopes, including cystoscopes, ureteroscopes, and cystourethroscopes. A 4/1 letter to healthcare providers says the agency has received numerous medical
Biologics
Johnson & Johnson is sending quality and compliance experts to its contract manufacturer Emergent Biosolutions after 15 million doses of its Covid-19 vaccine were determined to not meet “quality standards.” The doses were not expected to immediately be in the marketplace because the Baltimore (Bayview) manufacturing plant has been
Drugs
FDA says using Abbyy’s digital intelligence platform to analyze drug safety reports will save agency reviewers about 7,500 hours per year. An online GCN post says the platform transforms up to 120 fields in safety reports on potential adverse interactions during clinical drug trials into structured content that
Devices
FDA has granted Abbott an Emergency Use Authorization for over-the-counter, non-prescription, asymptomatic use of its BinaxNow Covid-19 Ag Self Test for detecting Covid-19 infection. The new indication allows individuals with or without symptoms to be tested without a prescription. According to the company, the test
Drugs
FDA says Apotex is recalling three lots of Guanfacine extended-release tablets 2 mg due to trace amounts of Quetiapine fumarate in one lot. A company announcement published by FDA says the administration of contaminated tablets can result in hypersensitivity reaction and may have additive effects in lowering blood pressure,
Drugs
FDA has approved Sanofi’s Sarclisa (isatuximab) for combination use with carfilzomib and dexamethasone in treating adult patients with relapsed or refractory multiple myeloma (RRMM) who have received one to three prior lines of therapy. The expanded approval was based on data from the Phase 3 IKEMA study, a randomized,
FDA Policy/General
Federal Register notice: FDA is correcting an 8/31/2016 amended final rule that listed inaccurate cross-references to FDA’s drug establishment registration and drug listing regulations. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Veryan Medical’s Biomimics 3D Vascular Stent System, indicated to improve luminal diameter in treating symptomatic de novo or restenotic lesions in the native superficial femoral artery and proximal popliteal arteries, with reference vessel diameters
Biologics
Special Counsel Henry Kerner says he agrees with an assertion by former FDA consumer safety officer Arie Menachem that the agency narrowly focused on procedural issues in its response downplaying Menachem’s whistleblower complaints and “disregards the fact that inspection reports detailing serious concerns were downgraded in a manner that
Devices
FDA says the Medical Device Innovation Consortium is seeking medical device manufacturers to participate in an Accelerate Sustainable Capability (ASC) pilot study that was developed in collaboration with the medical device industry, Information Systems Audit and Control Association, and FDA. An agency notice says the pilot study is intended to
FDA Policy/General
Federal Register notice: FDA is amending its medical device regulations to make an editorial nonsubstantive change and replace a reference to an obsolete office with updated information. The regulations specified in the notice have been revised to correct “director of the Office of Regulatory Program” to “director or Principal Deputy
FDA Policy/General
Federal Register notice: FDA has announced a 5/27 Endocrinologic and Metabolic Drugs Advisory Committee meeting. Panel members are scheduled to discuss the safety and efficacy of a Provention Bio BLA for teplizumab intravenous infusion, indicated for the delay or prevention of clinical Type 1 diabetes mellitus in at-risk