FDA Policy/General
Seven former FDA commissioners who served more than 30 years total in both Democratic and Republican administrations say the agency should be taken away from HHS and reconfigured into an independent federal agency. The seven spent 18 months examining FDA’s position within the federal government, its reporting relationships and
FDA Policy/General
As FDA enters the third week of the partial government shutdown, agency employees still on the job are facing challenges with fulfilling public health responsibilities, according to the Alliance for a Stronger FDA. The group has created an “FDA Shutdown Toolkit” that explains how agency operations are affected. During the
FDA Policy/General
FDA Webview has posted below the Federal Register notices published during our annual end-of-year holiday break. DEVICES Federal Register final rule: FDA has issued a final rule to amend its regulations governing medical device classification and reclassification to conform to the applicable provisions of the Food, Drug, and
FDA Policy/General
DEVICES FDA has cleared a Myoscience 510(k) for its iovera device for relieving pain and symptoms associated with osteoarthritis of the knee for up to 90 days. The device uses iovera’s technology and non-systemic treatment for blocking pain signals from peripheral nerves. It uses the “body’s
FDA Policy/General
FDA has announced that former Flatiron Health chief medical officer Amy Abernethy will replace retiring Rachel Sherman as the agency’s principal deputy commissioner. Previously, Abernethy served as a professor at Duke University School of Medicine and directed the Center for Learning Health Care in the Duke Clinical Research Institute.
Drugs
Some drug companies started 2019 with price increases on more than 250 prescription drugs, with more likely to come, according to multiple media reports. Relying on data from Rx Savings Solutions, which helps health plans and employers find lower cost prescription drugs, Reuters reports that Allergan raised prices on more
FDA Policy/General
Below are the FDA Warning Letters published during our annual end-of-year holiday break. Cao Medical Equipment Co. Hebei, China (11/30/2018): FDA inspected the firm 7/2018 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to perform, for each batch of drug
Drugs
Washington Legal Foundation (WLF) has called on the Centers for Medicare and Medicaid Services (CMS) to withdraw its proposed rule that would require drug makers to convey the wholesale acquisition cost of any prescription drug or biological product advertised in direct-to-consumer television ads. The advocacy group’s comment
FDA Policy/General
FDA commissioner Scott Gottlieb says a decline in the sales/distribution of antimicrobial drugs for food animals is “a reflection of improved antimicrobial stewardship.” Commenting on the agency’s 2017 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals, Gottlieb says it shows a 33% decline
FDA Policy/General
As FDA heads into 2019, it faces ongoing challenges from the partial government shutdown that now is in its second week — and no relief in sight for the impasse over a southern border wall. President Trump told the press during a 1/2 cabinet meeting that he will not budge
FDA Policy/General
Federal Register proposed rule withdrawal: FDA has announced the withdrawal of a proposed rule on “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products” that published 11/13/2013. FDA based its action on concerns expressed by commenters and considerations regarding agency resources. The agency is continuing to
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of nine ANDAs from multiple applicants. The applicants notified the agency they were no longer marketed and requested that their approval be withdrawn. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Data Integrity and Compliance With Drug CGMP: Questions and Answers.” The document has been developed in response to an increase in data integrity findings and concerns from recent inspections. To view the notice, click here.
FDA Policy/General
Ferdic, Inc., publisher of Dickinson's FDA Webview and other publications, wishes all readers Happy Holidays and a bright and prosperous New Year. Our newsroom is closed until Wednesday, January 2, 2019.
FDA Policy/General
Federal Register proposed rule: FDA has proposed to amend its regulation that defines “biological product” to incorporate changes made by the Biologics Price Competition and Innovation Act of 2009, and to provide its interpretation of the statutory terms “protein” and “chemically synthesized polypeptide.” Under that interpretation, the term protein would
FDA Policy/General
Federal Register notice: FDA has issued a priority review voucher to Novimmune for its approved rare pediatric disease product application for Gamifant (emapalumab-lzsg) injection, indicated for treating adult and pediatric (newborn and older) patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance with conventional
FDA Policy/General
Federal Register notice: FDA has determined that Akorn’s IC–Green (indocyanine green for injection), 10 milligrams (mg)/vial, 40 mg/vial, and 50 mg/vial, was not withdrawn from sale for reasons of safety or effectiveness. The determination will allow FDA to approve ANDAs for indocyanine green for injection,
FDA Policy/General
FDA says it has worked with Pfizer to help alleviate a shortage of certain injectable opioids available to treat pain in animals. An agency statement says it is facilitating the availability of a limited amount of product labeled for human use. The notice says that the Center for Veterinary Medicine
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Questions and Answers on Biosimilar Development and the BPCI Act.” The document is intended to inform prospective applicants and facilitate the development of proposed biosimilars and proposed interchangeable biosimilars, as well as to describe FDA’s interpretation of certain
FDA Policy/General
Federal Register notice: FDA has announced the availability of a final guidance entitled “Interpretation of the ‘Deemed To Be a License’ Provision of the Biologics Price Competition and Innovation Act of 2009.” This document describes FDA’s interpretation of the statutory provision under which an application for a biological product
FDA Policy/General
Federal Register notice: FDA has announced the availability of a draft guidance entitled “The ‘Deemed to be a License’ Provision of the BPCI Act: Questions and Answers.” The document is intended to provide answers to common questions about FDA’s interpretation of the statutory provision under which an application for
FDA Policy/General
Federal Register notice: FDA has announced a 5/21 public meeting entitled “FDA’s Proposed Current Good Manufacturing Practice Policies for Outsourcing Facilities: Considerations Regarding Access to Office Stock.” The meeting is intended to provide interested parties with an opportunity to present to FDA their perspectives concerning access to office