Drugs
Heron Therapeutics has resubmitted an NDA for HTX-011, an investigational agent for managing postoperative pain. The company expects a six-month review by the agency. The NDA was resubmitted based on feedback from an FDA/company meeting that sought clarity on an April complete response letter which requested additional
Drugs
FDA says it notified Shanghai Institute of Pharmaceutical Industry of a planned surveillance and pre-approval inspection of its drug product testing facility from 11/29-12/4/18 and the company refused the inspection in a 12/4/18 written response. A just-released 8/29 Warning Letter says
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it applauds FDA for the BEST (Biomarkers, EndpointS, and other Tools) resource taxonomy that serves as a point of consensus for all stakeholders and provides clarity needed to drive programs in biomedical research and clinical care. In a comment letter, PhRMA says
Drugs
FDA has issued a complete response letter to AstraZeneca for its NDA for PT010 (budesonide/glycopyrronium/formoterol fumerate), an inhaled triple-combination therapy for patients with chronic obstructive pulmonary disease. The company says the NDA included data from the KRONOS Phase 3 trial. It says AstraZeneca will now work closely
Drugs
FDA and the U.S. Drug Enforcement Administration have issued joint Warning Letters to four online networks that were illegally marketing unapproved and misbranded versions of opioid medicines, including tramadol. The letters ordered the networks to immediately stop illegally selling the opioids to American consumers. Additionally, an FDA notice said
Drugs
FDA has posted an 11-item Form FDA-483 to U.S. Specialty Formulations after concluding an inspection in July of its Bethlehem, PA manufacturing facility. According to the form, FDA cited it for not having written procedures for production and process controls. It also found that results of stability
Drugs
Federal Register notice: FDA has announced the fee rate of $2,167,116 for using a rare pediatric disease priority review voucher for fiscal year 2020. The vouchers are awarded to the sponsors of rare pediatric disease product applications when FDA approves them. To view the notice, click here.
Drugs
The government has charged Avanir Pharmaceuticals and four individuals with paying kickbacks to a physician to induce prescribing of its drug Nuedexta (dextromethorphan hydrobromide and quinidine sulfate), which is indicated for treating pseudobulbar affect (PBA), according to the U.S. Department of Justice. “Avanir has also agreed to pay over
Drugs
FDA has made available a draft guidance on “Patient-Focused Drug Development: Methods to Identify What Is Important to Patients.” The document describes how stakeholders (patients, researchers, medical product developers and others) can collect and submit patient experience data and other relevant information from patients and caregivers to be used
Drugs
FDA says it has awarded a new five-year contract to enhance its Sentinel System and prepare it for managing real-world data to improve the safety and effectiveness of drugs. The contract, which was awarded to two consortiums led by Harvard Pilgrim Health Care and Deloitte Consulting, will create
Drugs
FDA has approved Genentech’s Rituxan (rituximab) injection to treat granulomatosis with polyangiitis and microscopic polyangiitis in children two years of age and older in combination with glucocorticoids. An FDA release says it is the first approved treatment for children with these rare vasculitis diseases, in which a patient’s
Drugs
CDER’s Office of Prescription Drug Promotion (OPDP) has cited a Kowa Pharmaceuticals America direct-to-consumer patient testimonial video montage YouTube video about cholesterol-lowering Livalo (pitavastatin) because it makes false or misleading representations about the drug’s risks. A just-posted OPDP untitled letter says the video “misleadingly
Drugs
Federal Register notice: FDA has scheduled a 10/31 public meeting entitled “International Council on Harmonization (ICH) Global Meeting on E8 (R1) Guideline on General Considerations for Clinical Trials.” The meeting is intended to provide information on the increasing diversity of clinical trial designs and data sources being employed to
Drugs
Zogenix has resubmitted an NDA for Fintepla (fenfluramine hydrochloride) for treating seizures associated with Dravet syndrome. In April, FDA issued a “refusal to file” letter on the original NDA submission because a preliminary review determined that the NDA was not sufficiently complete to permit a substantive review, the company said
Drugs
CDER director Janet Woodcock says the reorganization aspect of the Center’s new drugs regulatory program modernization has cleared Congress and the next phase of the plan is being implemented. The intent of the modernization is to streamline resources so that doctors and staff can dedicate more time to drug
Drugs
A 9/27 joint meeting of the FDA Pediatric Advisory Committee and Drug Safety and Risk Management Committee is seeking members’ comments on a pediatric-focused safety review of neuropsychiatric events with the use of montelukast (Merck’s Singulair) asthma and allergy drug. An agency briefing document released in advance
Drugs
FDA has approved a Janssen Biotech supplemental BLA for use of Darzalex (daratumumab) in combination with bortezomib, thalidomide and dexamethasone for treating patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant. Approval was based on data from part one of the Phase 3 CASSIOPEIA study
Drugs
FDA says Apotex is recalling over-the-counter ranitidine tablets (75 mg and 150 mg), a generic form of Novartis’ Zantac labeled by Walgreens, Walmart, and Rite-Aid. An agency statement says the recalled tablets may contain low levels of a nitrosamine impurity, N-nitrosodiemthylamine (NDMA), which is classified as
Drugs
Three Drinker Biddle & Reath attorneys say a 7/9 FDA final guidance, Risk Evaluation and Mitigation Strategies: Modifications and Revisions, demonstrates the importance of classification. Writing online in the National Law Review, the three say that even though the categories lend themselves to a certain level of intuitiveness, “it
Drugs
FDA has approved an expanded indication for AbbVie’s Mavyret (glecaprevir and pibrentasvir) tablets for an eight-week duration for treating adults and children ages 12 and older or weighing at least 99 pounds who have chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection
Drugs
A systematic review and meta-analysis conducted by researchers from several locations around the world found that the magnitude of treatment effects was some 2.5-fold higher among treatments that were approved based on non-randomized clinical trials (RCTs) than among treatments that required further testing in RCTs. Writing
Drugs
FDA has renewed the legacy licenses for Certara’s Synchrogenix division’s electronic common technical document (eCTD) review software, GlobalSubmit Review and GlobalSubmit Validate, for another year. The agency has been using the software since 2005. Certara says the licenses provide enterprise-wide use of the GlobalSubmit software for more