Drugs
Consumer-health advocacy group Citizens for Health has urged FDA commissioner Scott Gottlieb to remove a Pew Charitable Trusts representative from the agency’s Pharmacy Compounding Advisory Committee (PCAC) due to alleged conflicts of interest in Pew’s lobbying support for pharmaceutical company interests. PCAC was created in 2014 and
Devices
A 2/5 FDA safety alert warns healthcare providers about reports of venous thromboembolism, including pulmonary embolism (PE), in patients who received autologous immune cell therapy using Therakos, Inc.’s Cellex Photopheresis System. “The onset of these events typically occurred during, or shortly after, active treatment sessions,” the alert says.
Drugs
FDA is reminding all ANDA and NDA holders about a one-time report that is due 2/14 on the market status for all approved drug products. The report is mandated in the recently enacted FDA Reauthorization Act of 2017 under Section 506I, which calls on all NDA and ANDA
Devices
United Health Products has submitted a PMA for HemoStyp for use in internal procedures. The company says it has submitted additional inspection and registration forms to the agency under its Critical-to-Quality pilot program for final approval and confirmation. It says HemoStyp is derived from regenerated oxidized cellulose, and
Drugs
CDER and CBER have released their “Data Standards Strategy FY2018-FY2022” that commits the Centers to continue the development, implementation, and maintenance of a comprehensive data standards program that will facilitate the pre- and post-market regulatory review process. “Together the two Centers will leverage their combined resources, talent and
Drugs
FDA has approved an Amag Pharmaceuticals supplemental NDA to broaden the existing label for Feraheme (ferumoxytol injection) beyond the current chronic kidney disease indication to include all eligible adult iron deficiency anemia patients who have intolerance to oral iron or have had unsatisfactory response to oral iron. Approval was based
FDA Policy/General
Regulatory Review Period Set for Edwards’ Sapien Valve Federal Register notice: FDA determines for patent extension purposes that the regulatory review period for Edwards Lifesciences’ Sapien XT Transcatheter Heart Valve is 1,370 days. 02/02/2018 Workshop on Modeling/Simulation for Oncology Products Federal Register notice: FDA announced a
FDA Policy/General
Dextera Surgical has agreed to sell all assets to Aesculap, a B. Braun company. The transaction includes the MicroCutter 5/80 Stapler, PAS-Port and C-Port automated anastomosis system cardiac surgery products, and the firm’s technology portfolio. In 12/2017, Dextera filed a voluntary Chapter 11 bankruptcy petition.
Drugs
Federal Register notice: FDA has determined for patent extension purposes that the regulatory review period for Duavee (conjugated estrogens/bazedoxifene acetate) is 5,683 days. Of this time, 5,317 days occurred during the testing phase and 366 days during the approval phase. Duavee is indicated for treating moderate to
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes that the regulatory review period for Edwards Lifesciences’ Sapien XT Transcatheter Heart Valve is 1,370 days. Of this time, 959 days occurred during the testing phase and 411 days occurred during the approval phase. The device is indicated for
Drugs
FDA has approved an Allergan supplemental NDA to expand the approved use of Avycaz (ceftazidime and avibactam) to include treating hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by the following susceptible Gram-negative microorganisms: Klebsiella pneumoniae, Enterobacter cloacae, Escherichia coli, Serratia marcescens, Proteus mirabilis, Pseudomonas aeruginosa, and
Devices
Kareway Products has recalled 60,000 lots of Gericare Eye Wash, Sterile Eye Irrigation Solution, four fluid ounces due to the potential for microbial contamination. “Use of the affected product could be calamitous for any population due to a probability of a potentially sight threatening eye infection or impairment,” an
Drugs
Federal Register notice: FDA has determined for patent extension purposes that the regulatory review period for Lenvima (lenvatinib mesylate) is 3,580 days. Of this time, 3,396 days occurred during the testing phase and 184 days during the approval phase. Lenvima is indicated for treating patients with locally recurrent
Drugs
Four House committee leaders overseeing FDA 2/2 wrote commissioner Scott Gottlieb expressing concern over the risk of worsening U.S. shortages of heparin due to new supply pressures in China, currently the source of 60% of the crude ingredients used to manufacture heparin here. In an extensively researched 13-
Drugs
A 2/2 letter to FDA from 92 bipartisan members of the U.S. Senate and the House urges the agency to use all tools at its disposal to address the dire shortages of IV saline and other critical medical products caused by Hurricane Maria that devastated Puerto Rico’s
Devices
CDRH director Jeff Shuren says that consumers should not be alarmed about findings from a new rodent study evaluating cell phone or radiofrequency energy exposure. In a 2/2 statement, Shuren said “we have not found sufficient evidence that there are adverse health effects in humans caused by exposures at
Drugs
Sens. Johnny Isakson (R-GA) and Bob Casey (D-PA) have introduced the Over-the-Counter Drug Safety, Innovation, and Reform Act (S. 2315) in a bipartisan effort to overhaul regulation of over-the-counter (OTC) monograph drugs. Attorney Riette van Laack (Hyman, Phelps & McNamara) writes in her firm’
Drugs
FDA was one of 16 federal agencies that developed a “strategic roadmap” with a new framework for safety testing of drugs and chemicals that will provide more human-relevant toxicology data while reducing the use of animals. The National Toxicology Program published the roadmap 1/30. The agencies say the
Devices
Yale University says that a team of its researchers found that FDA’s multi-stage review and alternation process for dermatologic devices has potentially dangerous loopholes. The team reports that many dermatologic devices had been altered after going through the review process, with limited agency inspection. After alteration, it says,
Drugs
FDA has ordered a Boxed Warning on Intercept Pharmaceuticals’ liver disease drug Ocaliva (obeticholic acid) after determining that it is being incorrectly dosed daily instead of weekly in patients with moderate to severe primary biliary cholangitis (PBC), a rare chronic liver disease, increasing the risk of serious liver injury. The
FDA Policy/General
Federal Register notice: FDA has announced a 2/1 public workshop entitled “Best Practices in Modeling and Simulation for Oncology Products.” The meeting will discuss integrating pharmacokinetic, pharmacodynamic, efficacy, and safety data into models to best inform oncology drug development, evaluate disease- and mechanism-specific early endpoints to predict long-
FDA Policy/General
Federal Register notice: FDA has determined that for patent extension purposes the regulatory review period for Les Laboratoires Servier’s Corlanor (ivabradine hydrochloride) was 293 days, with all of this time occurring in the approval phase. Corlanor is indicated to reduce the risk of hospitalization for worsening heart failure in