Drugs
Trevena has submitted an NDA for Olinvo (oliceridine injection) for treating pain. Olinvo, the sponsor says, was designed to improve conventional opioid pharmacology to deliver the pain-reducing potential of an opioid but with fewer associated adverse effects due to its biased ligand mechanism of action. The G protein-biased
Drugs
FDA has posted a final guidance on “Formal Dispute Resolution: Sponsor Appeals Above the Division Level” that provides recommendations for industry and review staff for resolving scientific and medical disputes between CDER or CBER and sponsors that cannot be resolved at the division level. A few examples of regulatory actions
FDA Policy/General
Federal Register notice: FDA has determined that Bayer’s Revex (nalmefene hydrochloride injection), which is indicated for reversing an opioid overdose, was not withdrawn due to safety or effectiveness issues. This determination will allow the agency to approve ANDAs referencing the product as long as other legal and regulatory requirements
Drugs
FDA has issued a draft guidance, Controlled Correspondence Related to Generic Drug Development, with information on the process by which generic drug manufacturers and related industry or their representatives can submit to FDA controlled correspondence requesting information related to generic drug development. The document also describes the agency’s process
Devices
FDA has cleared an IntraFuse 510(k) for its FlexThread Fibula Pin System that is intended to provide percutaneous fixation of distal fibula fractures, primarily Danis-Weber B type fractures, or trans-syndesmotic fractures. “Incorporating IntraFuse's proprietary FlexThread technology, the distal end of the implant is a flexible,
Drugs
FDA commissioner Scott Gottlieb says the agency is talking with drug companies about possible changes to opioid packaging to reduce access to the drugs. He told CNN that companies might find the agency’s action “disruptive” and “uncomfortable.” In addition to packaging changes, he said FDA could promote ways to
FDA Policy/General
Federal Register notice: FDA has announced the renewal of the Patient Engagement Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 10/6/2019. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring — OMB Control Number 0910-0409.” The regulations require diagnostic radiopharmaceutical manufacturers to submit information that demonstrates the safety and effectiveness of a new diagnostic radiopharmaceutical or of
Drugs
FDA Webview has posted the court-approved consent decree between FDA and Philips North America that prohibits manufacturing, processing, packing, holding, or distributing medical devices made by the firm’s Emergency Care and Resuscitation business unit at facilities in Andover, MA, and Bothell, WA, until they comply with agency regulations
Devices
Abbott Quality & Regulatory says a draft FDA guidance on “Deciding When to Submit a 510(k) to an Existing Device” interprets a “major change in intended use” to be a type of change that “could significantly affect safety or effectiveness,” which is inconsistent with current regulatory language. In its
Drugs
FDA has accepted a Bayer BLA for BAY94-9027, an extended half-life PEGylated recombinant human Factor VIII compound for treating hemophilia A in adults and adolescents 12 years of age and older. The submission is based on data from the PROTECT VIII pivotal Phase 2-3 trial that was
FDA Policy/General
Federal Register notice: FDA is seeking nominations for a nonvoting industry representative to serve on its Pediatric Advisory Committee. Nominees may either be self-nominated or nominated by an organization. Nominations received on or before 12/4 will be given first consideration for membership on the panel. To view the
FDA Policy/General
Federal Register notice: FDA has announced an 11/30 public meeting on “Assessment of FDA Hiring and Retention” that will share high-level findings from a recently completed examination of the agency’s hiring process conducted by an independent contractor. It will also outline actions FDA will or can take
Devices
During a recent FDA Webinar on an agency final guidance on design considerations and premarket submission requirements for interoperable medical devices, CDRH senior science health advisor Heather Agler said the agency suggests that companies design systems with interoperability as an objective. “Think about this upfront when you’re thinking about
Drugs
FDA has approved a Bausch + Lomb and Nicox NDA for Vyzulta (latanoprostene bunod ophthalmic solution, 0.024%), indicated for reducing intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The once daily therapy has a dual mechanism of action, according to the company, and works by metabolizing into
Devices
A Massachusetts federal judge has entered a consent decree of permanent injunction sought by FDA against Philips North America and two of its officers, generally prohibiting them from manufacturing, processing, packing, holding, or distributing medical devices made by the firm’s Emergency Care and Resuscitation (ECR) business unit at facilities
FDA Policy/General
Federal Register notice: FDA has made available an International Council for Harmonization draft guidance entitled “E9 (R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials.” The document is intended to clarify, update, and extend the earlier ‘‘E9 Statistical Principles for Clinical Trials’’ in two main
FDA Policy/General
Federal Register notice: FDA has announced a 12/11-12 public workshop on “Packaging, Storage, and Disposal Options To Enhance Opioid Safety — Exploring the Path Forward” that will host a scientific discussion on the role of packaging, storage, and disposal options in order to curb inappropriate access to prescription opioid
Drugs
FDA has denied a 2/26/16 Empire State Consumer Project (ESCP) petition asking that it test all brands of OTC and prescription drug products containing polyethylene glycol 3350 (PEG 3350) for the presence of selenium, determine the source of any selenium found in the tested products, and issue a
Drugs
FDA has denied a Pharmaceutical Manufacturing Research Services (PMRS) 5/11 petition to stay the effective date of the approval of Inspiron’s Roxybond (oxycodone hydrochloride) with labeling claims pertaining to chronic use and abuse deterrence until the agency issues substantive written responses to two earlier PMRS petitions. The denial
Drugs
Federal Register notice: FDA is seeking comments on an information collection extension on the “Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic.” The guidance includes recommendations for planning, notification, and documentation for firms that report postmarketing adverse events. The guidance
FDA Policy/General
FDA has sent Warning Letters to four companies that marketed marijuana-derived products as cancer treatments. “Selling these unapproved products with unsubstantiated therapeutic claims is not only a violation of the Federal Food, Drug and Cosmetic Act, but also can put patients at risk as these products have not been