FDA Policy/General
Federal Register notice: FDA has announced an educational conference co-sponsored with the Society of Clinical Research Associates on the agency’s clinical trial requirements. The 11/15-16 conference will be held in Lake Buena Vista, FL, and is designed to aid clinical researchers’ understanding of the informed consent
Drugs
Guide on Index of Unapproved New Animal Drugs Federal Register notice: FDA makes available a draft guidance #210 entitled “The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species.” 09/22/2017 PMA Summaries Available for CBER-approved Products Federal Register notice: FDA makes available the safety and
FDA Policy/General
Federal Register notice: FDA is seeking comments on a information collection extension for its “Certification To Accompany Drug, Biological Product, and Device Applications or Submissions (Form FDA 3674).” The agency says the information contained in the form is necessary to satisfy a statutory requirement on adherence to the legal requirements
FDA Policy/General
Federal Register notice: FDA has announced an 11/7 Vaccines and Related Biological Products Advisory Committee meeting. Panel members are scheduled to discuss and make recommendations on a clinical development plan for Pfizer’s investigational Staphylococcus aureus vaccine intended for pre-surgical prophylaxis in elective orthopedic surgical populations. To view
Drugs
Researchers from the Dartmouth Institute for Health Policy and Clinical Practice believe FDA should be doing more to ensure pharmaceutical sponsors meet post-approval study deadlines. With many approval candidates lagging on safety and effectiveness when drugs are first approved, the agency requires post-approval (Phase 4) studies to further
Drugs
FDA has granted accelerated approval to Merck’s Keytruda (pembrolizumab) for treating patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 as determined by an FDA-approved test. The expanded approval is intended for patients experiencing disease progression on or after two
Devices
FDA has approved magnetic resonance (MR)-conditional labeling for Abbott’s Ellipse implantable cardioverter defibrillator and associated Tendril MRI pacing lead and Durata and Optisure high voltage leads. Ellipse labeling allows patients to undergo an MRI scan if needed, and patients previously implanted with an Ellipse device and Durata or
Drugs
FDA has issued Janssen Biotech a complete response letter on a BLA for sirukumab and its use in treating moderately to severely active rheumatoid arthritis. The agency letter indicated that additional clinical data are needed to further evaluate the therapy’s safety, according to the company. Janssen plans to have
FDA Policy/General
Federal Register notices: FDA has made available a draft guidance entitled “Statistical Approaches to Evaluate Analytical Similarity.” The document is intended to provide advice on evaluating analytical similarity to sponsors interested in developing biosimilar products. Specifically, it describes the type of information biosimilars should obtain about the structural/physicochemical and
Drugs
Aegerion Pharmaceuticals has agreed to plead guilty in the Massachusetts federal court to two misdemeanor misbranding charges involving Juxtapid (lomitapide), indicated as an adjunct therapy to treat homozygous familial hypercholesterolemia (HoFH), a rare disorder that that causes high cholesterol levels and early cardiovascular disease. According to the government, Aegerion failed
Drugs
The 5th Circuit Court of Appeals has upheld a Texas federal court grant of summary judgment to Solvay Pharmaceuticals in a False Claims Act (FCA) case brought by two whistleblowers alleging that the company induced false Medicaid claims through off-label marketing and kickbacks to promote Luvox, Aceon, and AndroGel.
Drugs
FDA has published a draft guidance, Statistical Approaches to Evaluate Analytical Similarity, with agency advice on the evaluation of analytical similarity for sponsors interested in developing biosimilar products under the Biologics Price Competition and Innovation Act of 2009. Specifically, the document says, it describes the type of information a sponsor
Drugs
An FDA safety alert warns that Intercept Pharmaceuticals’ liver disease drug Ocaliva (obeticholic acid) is being incorrectly dosed in some patients with moderate to severe decreases in liver function, resulting in an increased risk of serious liver injury and death. “Ocaliva may also be associated with liver injury in some
Devices
FDA has cleared a Brainlab 510(k) for Elements Spine SRS and Elements Cranial SRS, two software applications that aid in the patient-tailored planning of radiosurgery treatments for the spine and brain. The software can create radiosurgery plans in less than 15 minutes from start to finish, the company
Drugs
Public Citizen has filed suit against FDA in DC federal court over the agency’s failure to rule on the advocacy group’s three-year-old petition asking that it address life-threatening health risks associated with benzocaine, an ingredient common in certain infant teething and other medicines. The suit
Devices
Attorney Mark DuVal (DuVal & Associates) faults FDA for what he contends is its recent adoption of a “shut down” mentality when reviewing medical device 510(k) submissions. “They often spend much of their time trying to conjure up countervailing arguments why a device does not belong on the 510(
Drugs
FDA has cleared a ClaroNav 510(K) for NaviENT, a computer-assisted surgical navigation system for surgical procedures inside a patient’s skull. The device provides three-dimensional visualization and assists surgeons in navigating patient sinuses while avoiding areas like the optic nerve and brain, the company says. The system
FDA Policy/General
Federal Register notice: FDA has announced a 10/24-25 public meeting entitled “2017 Scientific Meeting of the National Antimicrobial Resistance Monitoring System.” The meeting is intended to discuss the current status of the National Antimicrobial Resistance Monitoring System. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced a 10/27 public workshop entitled “FDA-University of Maryland CERSI Drug Development in Pediatric Heart Failure: Extrapolation, Clinical Trial Design, and Endpoints.” The meeting is intended to address challenges related to the evaluation of products in pediatric heart failure including study population, endpoints,
FDA Policy/General
Federal Register notice: FDA has announced a 10/13 meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee. Panel members will discuss the safety and efficacy of a Aerie Pharmaceuticals NDA for netarsudil ophthalmic solution 0.02%, indicated for reducing elevated intraocular pressure in patients with open-angle glaucoma or
Drugs
Four FDA officials say that in the period FY 2010-2014, FDA allowed 98% of individual patient expanded-access requests to proceed. Writing in The Journal of Clinical Pharmacology, the four say that for individual expended access requests, FDA must determine that: * the patient to be treated has a serious
Drugs
The FDA request for stakeholder views on ensuring a balance between innovation and access in the Waxman-Hatch amendments has brought diverse views. In its response, Vifor Pharma says that generic forms of non-biological complex drugs (NBCDs) should not be approved via the ANDA pathway. It asks the agency