Drugs
FDA has partially granted an Allergan petition (submitted by Hyman Phelps & McNamara) seeking added bioequivalence assurances for irritable bowel syndrome drug Linzess (linaclotide). The petition urged the agency to require ANDA applicants seeking approval for generic Linzess to “demonstrate bioequivalence to Linzess in a clinical endpoint bioequivalence study.” In
Devices
FDA commissioner Scott Gottlieb and CDRH director Jeffrey Shuren say the agency has taken two additional steps to spur innovation of medical products so that patients can have access to safe, effective treatments that improve or save lives. They say the Safer Technologies Program (STeP) aims to encourage innovation and
Drugs
FDA has updated the list of off-patent, off-exclusivity drugs without an approved generic that it maintains to improve transparency and encourage development and submission of applications under an abbreviated pathway for drugs with limited competition. The list includes approved NDAs for drug products that are not protected by
Drugs
FDA has published interim acceptable levels of nitrosamine impurities in angiotensin II receptor blockers (ARBs) for manufacturers to use to ensure that finished drug products are safe for patients. An agency notice says FDA evaluated safety data for N-nitrosodiemthylamine (NDMA) and N-nitrosodiethylamine (NDEA) to determine an interim acceptable
Drugs
FDA has approved Celltrion’s Herzuma (transtuzumab-pkrb) as a biosimilar to Genentech’s Herceptin (transtuzumab) for patients with HER2-overexpressing breast cancer. An agency notice says Herzuma is a HER2/neu receptor antagonist indicated to treat HER2-overexpressing breast cancer. The Herzuma prescribing information says common expected side effects
Drugs
FDA has published a finalized guidance, Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics, that revises and replaces a 5/2007 draft guidance. The document gives recommendations to applicants on endpoints for cancer clinical trials submitted to FDA to support effectiveness claims in NDAs, BLAs, or supplements.
Drugs
FDA has approved Stemline Therapeutics’ Elzonris (tagraxofusp-erzs) infusion to treat blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and pediatric patients age two and older. An agency announcement says BPDCN is an aggressive and rare disease of the bone marrow and blood that can affect multiple organs, including the
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
Drugs
Sen. Elizabeth Warren (D-MA) introduced at the end of 2018 the Affordable Drug Manufacturing Act that would authorize HHS to manufacture select generic drugs and offer them to consumers at a fair price, guaranteeing affordable patient access. Rep. Jan Schakowsky (D-IL) was to introduce companion legislation in the
Drugs
FDA says Aurobindo Pharma has recalled two lots of valsartan tablets, 26 lots of amlodipine and valsartan combination tablets, and 52 lots of valsartan and hydrochlorothiazide combination tablets due to the amount of N-Nitrosodiethylamine (NDEA) in the valsartan active pharmaceutical ingredient. The agency notice says that Aurobindo is recalling
Devices
An independent Booz Allen report assessing FDA’s medical device review process as required by MDUFA 3 and MDUFA 4 says that CDRH staff are aware of and use the products and resources developed and implemented by the Center for all recommendations the consultants made as part of their initial
Drugs
FDA commissioner Scott Gottlieb says the agency is taking steps to strengthen a mandated post-marketing study for Bayer’s Essure permanent birth control device that was withdrawn from the market 12/31/18. In a statement, Gottlieb says the agency worked with Bayer to see that it implements several
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
Devices
FDA has posted a draft guidance entitled “Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment.” The document provides clarification on the regulations that pertain to diagnostic x-ray systems and their major components. It contains two sections — one on general information relating to diagnostic x-ray
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
Devices
FDA has released a guidance entitled “Manufacturing Site Change Supplements: Content and Submission.” The document explains FDA’s current thinking on what constitutes a manufacturing site change and when you should submit a PMA supplement for a site change. It also addresses the documentation that should be submitted in a
Devices
FDA has cleared an EhmetDx 510(k) for its 3D CBCT (cone beam computed tomography) positioning software to be used in patient treatment at the McLaren Proton Therapy Center. The system is used to precisely guide the position of the proton beam in patient treatments, the company says.
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.
Drugs
FDA has approved a Celltrion BLA for Herzuma (trastuzumab-pkrb) as a biosimilar to Genentech’s Herceptin (trastuzumab) for patients with HER2-overexpressing breast cancer. Common adverse events include headache, diarrhea, nausea, chills, fever, infection, congestive heart failure, insomnia, cough, and rash. Serious expected side effects of Herzuma include worsening
Drugs
Senators Richard Blumenthal (D-CT), Kamala Harris (D-CA), Jeff Merkley (D-OR), and Amy Klobuchar (D-MN) have introduced the Curbing Unreasonable Rises and Excessively (CURE) High Drug Prices Act today to prohibit unjustified drug price increases. The measure would give HHS the authority to block such increases and