FDA Policy/General
Federal Register Notice: FDA has released a draft guidance entitled “FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary.” The document is intended to clarify how the agency applies certain factors in determining whether a risk evaluation and mitigation strategy (REMS) is necessary to ensure that
FDA Policy/General
Reps. Fred Upton (R-MI), chairman of the House Energy and Commerce Committee, and Rep. Tim Murphy (R-PA), who heads the committee’s Oversight and Investigations Subcommittee, are asking (includes link to committee letter) FDA for an update on its Office of Criminal Investigations (OCI) in the wake of
Drugs
UK researchers say there is strong evidence that much of the information on adverse events remains unpublished and that the number and range of adverse events is higher in unpublished than in published versions of the same study. Writing in the open-source journal PLOS Medicine, the authors say their
Devices
FDA has cleared a K2M Group Holdings 510(k) for screw and connector components for a spine application used with its MESA Spinal System. The company says this clearance enables the screw and connector components to be used as a part of a growing rod construct designed to accommodate growth
FDA Policy/General
Federal Register Notice: FDA has announced the availability of a draft guidance entitled “Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices.” The document is intended to assist drug sponsors and device manufacturers who are planning to develop new antimicrobial drugs and antimicrobial susceptibility test (AST) devices and who
FDA Policy/General
Federal Register Notice: FDA has released a guidance entitled “Reporting of Computational Modeling Studies in Medical Device Submissions.” The document provides recommendations to industry on the formatting, organization, and content of reports of computational modeling and simulation studies that are used as valid scientific evidence to support medical device submissions,
FDA Policy/General
Federal Register Notice: FDA has announced a publication containing modifications to the agency’s list of standards it recognizes for use in premarket reviews (FDA Recognized Consensus Standards). The document, “Modifications to the List of Recognized Standards, Recognition List Number: 045,” is intended to assist manufacturers who elect to declare
Drugs
FDA has approved a Janssen Pharmaceuticals supplemental NDA for Invokamet XR (canagliflozin and metformin hydrochloride) for first-line use as an adjunct to diet and exercise to improve blood glucose control in adults with Type 2 diabetes when treatment with the two medications is appropriate. The new indication aligns with
Drugs
Members of 16 public health, patient advocacy, health professional, and disease organizations are voicing concerns about proposed legislation that they say will weaken drug safety protections and make it easier for potentially dangerous drugs to get into the wrong hands. Members of the Patients’ Alliance for Drug Safety Protections say
FDA Policy/General
Federal Register Notice: FDA is suspending approval of an Armenpharm, Ltd. ANDA for chloramphenicol capsules, 250 mg because previous versions of chloramphenicol were withdrawn from sale for reasons of safety or effectiveness. The agency says it will not accept or approve ANDAs for chloramphenicol capsules, 50 mg and 100 mg,
FDA Policy/General
The 2nd Circuit Court of Appeals has ruled that a Lanham Act false advertising claim brought by Church & Dwight against Swiss Precision Diagnostics (SPD) over its Clearblue Advanced Pregnancy Test with Weeks Estimator is not precluded by the Federal Food, Drug, and Cosmetic Act (FFDCA). Church & Dwight claimed
Devices
FDA has cleared a Heidelberg Engineering 510(k) to market its Spectralis OCT Glaucoma Module Premium Edition that is intended to provide a comprehensive analysis of the optic nerve head, retinal nerve fiber layer, and ganglion cell layer by precisely matching unique scan patterns to the fine anatomic structures relevant
Drugs
FDA has accepted for review a TherapeuticsMD NDA for Yuvvexy, an investigational bio-identical 17β-estradiol vaginal softgel capsule for treating moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar vaginal atrophy in postmenopausal women. The agency has set a user fee review target date of
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Option Care Enterprises, Inc. Everett, WA (9/7). FDA investigators inspected the drug compounding operation and observed deficiencies in its practices for producing sterile drug products. For example, the
Drugs
FDA has released a draft guidance on “FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary” that is intended to clarify how it applies factors in determining whether a risk evaluation and mitigation strategy (REMS) is necessary to ensure that the benefits of a drug outweigh
Drugs
FDA has issued for comment a draft guidance, Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices, to assist drug sponsors and medical device manufacturers who are planning to develop new antimicrobial drugs and antimicrobial susceptibility test (AST) devices and who seek to coordinate development of the products such
Devices
FDA has issued a guidance, Reporting of Computational Modeling Studies in a Medical Device Submission, with recommendations for industry on the formatting, organization, and content of reports of computational modeling and simulation (CM&S) studies used to support medical device submissions. The document says its recommended format aims to
Drugs
Alcon has petitioned FDA to change the bioequivalence testing requirements for any ANDA that cites its Durezol (difluprednate ophthalmic emulsion, 0.05%) as the reference-listed drug and also revise the product-specific bioequivalence draft guidance for difluprednate ophthalmic emulsion. “Petitioners believe that only in vivo pharmacokinetic testing or comparative
Drugs
Alcon is asking FDA to require only in vivo bioequivalence testing for ANDAs that cite its Ciprodex (ciprofloxacin 0.3% and dexamethasone 0.1%) sterile otic suspension as the reference-listed drug. It also asks that the agency revise its product-specific guidance on ciprofloxacin and dexamethasone. Specifically, the petition
Drugs
One in 13 investigational diabetes drugs receive FDA marketing approval, compared to one in eight of all drugs, making diabetes drugs the riskiest drugs to develop, according to a Tufts Center for the Study of Drug Development Impact Report analysis (subscription required). The analysis finds that investment in drug development
Devices
CDRH says its 10 FY 2017 regulatory science priorities will be a “catalyst to improving the safety, effectiveness, performance, and quality of medical devices and radiation-emitting products” and will facilitate introducing innovative medical devices into the marketplace. The priorities will be reassessed and updated periodically to reflect current regulatory
Devices
Attorney James Beck (Reed Smith) says that causation in failure-to-report claims is necessarily roundabout because, as the 9th Circuit Court of Appeals held in 2013, “any attempt to predicate the claim on an alleged state law duty to warn doctors directly would have been expressly preempted.” Writing in