Drugs
FDA has published a guidance, Safety Testing of Drug Metabolites, with recommendations to industry on when and how to identify and characterize drug metabolites whose nonclinical toxicity needs to be evaluated. The document applies to small molecule nonbiologic drug products and does not apply to some cancer therapies. FDA says
Drugs
FDA says it has launched its new PDUFA performance dashboards at FDA-TRACK the agency performance management program. “These dashboards offer a more concise, interactive, and visual presentation of some of the data reported in FDA’s legislatively mandated annual PDUFA report to Congress,” an agency announcement says. The dashboards
Devices
Bipartisan legislation has been introduced in the House and Senate to increase the diagnostic capabilities of health laboratories across the U.S., in part to better respond to emerging public health threats such as the novel coronavirus. The bill follows complaints from public health officials that a current FDA policy
FDA Policy/General
Federal Register notice: FDA has announced the completion of the first phase of its enhanced Purple Book for biologics. The agency says it is transitioning the publication’s current table format to a searchable, public-facing online database entitled “Purple Book: Database of FDA-Licensed Biological Products.” A docket for
Devices
FDA has announced a 4/7 public meeting on reauthorizing the Medical Device User Fee Amendments for fiscal years 2023 through 2027 (MDUFA V). The current device user fee program expires on 10/1/2022, and new legislation will need to be enacted beforehand to allow user fee collection and
Drugs
FDA commissioner Stephen Hahn says the agency is taking additional steps to educate consumers and healthcare providers about cannabidiol (CBD) products and to obtain additional data to help evaluate those products. In a statement released online 3/5, Hahn says the agency recently updated the public on concerns about potential
Devices
[Report by David McFarland] The Trump Administration continues to lose credibility with its handling of the coronavirus outbreak. After promising to deliver up to 1.5 million tests for coronavirus by the end of the week, vice president Mike Pence now says that goal won't be met and
Devices
FDA has published a final rule to ban electrical stimulation devices used for self-injurious or aggressive behavior. An agency media statement says the devices “present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated through new or updated device labeling.” The devices administer
Drugs
FDA has published a guidance to provide answers to common questions about the agency implementation of the “transition” provision of the Biologics Price Competition and Innovation Act of 2009. Under that act, the document says, an application for a biological product approved under section 505 of the Federal Food, Drug,
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Current Good Manufacturing Practice Regulations for Medicated Feeds — 21 CFR Part 225” (OMB Control Number 0910-0152). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has determined the regulatory review period for patent extension purposes for Kyowa Hakko Kirin’s Fasenra (benralizumab), indicated for the add-on maintenance treatment of patients with severe asthma aged 12 years and older and with an eosinophilic phenotype. The review period is 4,127 days,
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Soft (Hydrophilic) Daily Wear Contact Lenses — Performance Criteria for Safety and Performance Based Pathway.” Under the pathway, a new device can demonstrate performance characteristics of a legally marketed device to receive marketing authorization. Instead of reviewing data from direct
Drugs
Valisure, which describes itself as an online pharmacy and analytic laboratory that is accredited by the International Organization for Standardization and registered with FDA and the Drug Enforcement Administration, says it has tested and detected high levels of N-Nitrosodimethylamine (NDMA) in specific batches of prescription drug products containing metformin,
Drugs
Researchers from academic institutions in the UK and Belgium say their study of 63 of the 355 new therapeutic drugs and biologic agents approved by FDA between 2009 and 2018 shows that the estimated median capitalized research and development cost per product was $985 million, counting expenditures on failed trials.
Drugs
The U.S. government has filed a False Claims Act suit in Massachusetts federal court against Mallinckrodt ARD (previously Questcor Pharmaceuticals) for allegedly underpaying Medicaid rebates caused by large increases in the pricing for its drug H.P. Acthar Gel. The government’s complaint alleges that despite Acthar being first
Drugs
FDA says it is requiring a Boxed Warning for Merck’s Singulair (montelukast sodium) and its generic forms to strengthen an existing warning about the risk of neuropsychiatric events associated with the drug that is indicated to treat asthma and allergic rhinitis. The Boxed Warning will advise healthcare providers to
Drugs
[Analysis by David McFarland] Missteps by federal agencies and the Trump Administration grappling with the coronavirus outbreak will no doubt make a nice “lessons learned“ case study one day on what not to do the next time the U.S. faces a pandemic. Because we at FDA Webview tend to
Devices
FDA has cleared a Biogennix 510(k) for an expanded indication for its Agilon moldable bone grafting product — use in posterolateral spine procedures when mixed with autograft. The device contains a high purity, Type 1 fibrillar bovine collagen, which is intended to provide a site for cell attachment, migration, proliferation,
FDA Policy/General
Federal Register notice: FDA has announced a 4/14 public meeting entitled “International Cooperation on Cosmetics Regulation (ICCR) — Preparation for ICCR–14 Meeting.” The meeting intends to invite public input on various topics on regulating cosmetics that may be used in preparing for the ICCR meeting in Brussels 6/8-
FDA Policy/General
Federal Register notice: FDA has made available 33 new and 10 revised draft product-specific guidances that provide recommendations on, among other things, bioequivalence study designs to support ANDAs. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Bone Anchors — Premarket Notification (510(k)) Submissions.” The document provides recommendations for 510(k) submissions for bone anchor (suture anchor) devices, including performance testing recommendations and device descriptions. To view the notice, click here.
Drugs
A 5/21-5/28/19 FDA inspection at Market America, Greensboro, NC, found multiple violations in the firm’s distribution of dietary supplements that are contract manufactured for it under the firm’s name. A just-released 2/12 Warning Letter says the company failed to submit a Serious