FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Data to Support Social and Behavioral Research as Used by the Food and Drug Administration” (OMB Control Number 0910-0847). FDA says it is important to understand patients, consumers, and healthcare professionals’ perceptions and behaviors to improve
Devices
FDA has approved a Flowonix Medical PMA to market the Prometra II 40 mL Programmable Infusion Pump and its associated programmer software. The device has expanded reservoir size options to include both 20 mL and 40 mL pumps, and also includes a claim of a 10-year battery life at
Drugs
An FDA safety alert warns that CholesLo, a product promoted and sold for lowering cholesterol on various Web sites, including www.choleslo.com, contains an undeclared ingredient. An agency laboratory analysis confirmed that CholesLo contains undeclared lovastatin, which is the active ingredient in Merck’s Mevacor and generic equivalents, the
FDA Policy/General
The Washington Post says it has learned that President Donald Trump is about to name MD Anderson chief medical officer Stephen Hahn to be FDA commissioner, succeeding acting commissioner Ned Sharpless. The Post says Hahn, 59, is a radiation oncologist and researcher who has been described as an “energetic consensus-
Devices
FDA has granted Fresenius Medical Care a breakthrough device designation for its new hemodialysis system that aims to prevent blood clotting without the use of blood thinner medication in most patients. The antithrombogenic additive, Endexo, is being incorporated into the manufacturing process of dialyzers and bloodlines, the company says. Endexo
Devices
FDA is recommending that manufacturers of breast implants incorporate a Boxed Warning and patient decision checklist into the device labeling “to better ensure certain information is received and understood by patients.” A new draft guidance, Breast Implants—Certain Labeling Recommendations to Improve Patient Communication, also recommends updated and additional labeling
Drugs
FDA has issued a draft guidance, Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act, with information on the provision in the law authorizing FDA to require certain postmarketing studies and clinical trials for certain prescription drugs and biological products.
Devices
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Premarket Approval of Medical Devices” (OMB Control Number 0910-0231). Premarket approval application (PMA) requirements assist in the agency’s scientific and regulatory review to ensure the safety and effectiveness of Class 3 devices. PMA requirements apply
Drugs
Federal Register notice: FDA has submitted to OMB an information collection extension for “Postmarket Surveillance of Medical Devices — 21 CFR Part 822” (OMB Control Number 0910-0449). The Food, Drug, and Cosmetic Act authorizes the agency to require a manufacturer to conduct postmarket surveillance (PS) of any device that meets
Drugs
Harvard Medical School researchers say that although the level of biosimilar testing needed for FDA approval exceeded the European Medicines Agency (EMA) level soon after the FDA biosimilar pathway was established, that is no longer the case. The researchers looked at 16 biosimilars of nine originator biologics that had been
Biologics
FDA has given the green light to BlueWillow Biologics to conduct a Phase 1 study of its next-generation intranasal anthrax vaccine candidate BW-1010. The study is being funded by NIHֺ’s National Institute of Allergy and Infectious Diseases. Product development is ongoing through BlueWillow’s partnership with Porton
Drugs
FDA has announced a 12/5 public meeting on its Standard Core Clinical Outcome Assessments (COAs) and Endpoints Pilot Grant Program. The meeting is intended to allow grantees to share their development plans for the standard core COA sets and to receive feedback from stakeholders. FDA will also provide an
Devices
Researchers say the FDA policy for health and wellness app regulation is ethically problematic and the agency should take much more responsibility to regulate all such apps. Writing online in the journal Bioethics, the researchers say that FDA currently does not regulate health and wellness apps that are not intended
Drugs
FDA has granted Moderna a fast track designation for mRNA-3927, its investigational mRNA therapeutic for propionic acidemia. The company announced an open IND for mRNA-3927 on 9/30. Moderna says it is preparing to initiate a Phase 1/2 clinical study to evaluate the therapy’s potential to
Devices
The National Council on Disability (NCD), an independent federal agency, is calling on FDA to end its enforcement discretion and regulate laboratory diagnostic tests, and particularly noninvasive prenatal screenings, that it says have made prenatal genetic testing more commonly available to women of different ages, socioeconomic backgrounds, and health histories.
Drugs
Provention Bio says its Phase 2 PRINCE clinical trial evaluating twice-daily Crohn’s disease drug PRV-6527, an oral Colony Stimulating Factor-1 Receptor (CSF-1R) small molecule inhibitor, showed that the therapy did not perform better that placebo. The study enrolled 93 moderate-to-severe Crohn’s disease
Drugs
FDA has released the FDA-483 issued following a 6/19-6/23 inspection at East Marietta Drug Company, Marietta, GA, a producer of non-sterile drug products. The three inspection observations on the form were: * production of highly potent drugs without providing adequate cleaning of work surfaces to prevent
Drugs
FDA has denied all requests in a Public Citizen 6/29/16 petition involving dopamine agonists and most requests in a BioMedEcon 6/2/17 petition involving certain specific dopamine agonists. Public Citizen had asked that FDA (1) add a Boxed Warning to labeling for all dopamine agonists describing the
Devices
Attorney Jeffrey Shapiro (Hyman, Phelps & McNamara) says FDA can resolve its “worst of all worlds” oversight of laboratory-developed tests (LDT) by standing down until Congress sets the authorized terms of the agency’s role in LDT oversight. Writing in his firm’s FDA Law Blog, Shapiro reviews the
FDA Policy/General
FDA and FTC have posted a joint Warning Letter to Rooted Apothecary (Naples, Florida) for illegally selling unapproved products containing cannabidiol online that made unsubstantiated claims for treating teething pain and ear aches in infants, autism, attention-deficit/hyperactivity disorder, Parkinson’s and Alzheimer’s disease, among other conditions or
Biologics
FDA has made available a final guidance entitled “Submitting Study Datasets for Vaccines to the Office of Vaccines Research and Review.” The technical specifications document provides detailed information and specifications for the content of datasets submitted to CBER. It is also intended to aid clinical and statistical reviewers in the
Drugs
FDA has made available a final guidance entitled “Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER Questions and Answers.” The document is intended to clarify agency expectations on facility information that should be included in original NDAs, ANDAs, BLAs, and chemistry, manufacturing, and controls supplements. It discusses