Devices
Bayer vice president Steven Immergut 12/7 disputed a complaint by Rep. Rosa DeLauro (D-CT) as reported by FDA Webview 12/4 that the company is under-performing on a commitment it made to FDA to study the post-marketing experience with its controversial permanent birth-control device, Essure.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Pediatric Rare Diseases — A Collaborative Approach for Drug Development Using Gaucher Disease as a Model.” The document proposes for consideration a novel approach to improve drug development efficiency in pediatric rare diseases using Gaucher disease as an example. It
Drugs
FDA has asked Primus Pharmaceuticals (Scottsdale, AZ) to recall Limbrel, a capsule marketed to “manage the metabolic processes associated with osteoarthritis.” The agency says the product is marketed as a medical food, but a preliminary determination suggests that Limbrel is an unapproved new drug. A safety alert notes that so
Drugs
CDER Office of New Drugs deputy director Peter Stein says it is important for the public to know that most drug post-approval studies are on track. “When studies are delayed,” he says in an FDA Voice blog post, “FDA works with manufacturers to identify the reasons for the delays
Drugs
Responding to an FDA request for comment on whether the agency should develop a list of pre-1994 ingredients that would be presumed safe for use in dietary supplements under the Dietary Supplement Health and Education Act of 1994, the Center for Science in the Public Interest says it believes
Devices
FDA has cleared a Camber Spine 510(k) for the SPIRA-C Open Matrix Cervical Interbody device, an interbody fusion implant. The 3D-printed titanium implant is designed to enhance fusion, according to the company. It uses the company’s SPIRA Arch Technology that creates an environment for cell proliferation
Drugs
FDA has approved a Sunovion Pharmaceuticals NDA for Lonhala Magnair (glycopyrrolate) inhalation solution (25 mcg twice daily) for the long-term, maintenance treatment of airflow obstruction in people with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. The company says the product is the first nebulized long-acting
Drugs
Senator Joe Manchin (D-WV) has called on FDA to adopt three policy changes through its Opioid Policy Steering Committee to reduce unnecessary and dangerous opioid medications. In a 12/6 letter to FDA commissioner Scott Gottlieb, Manchin offered support for the steering committee. He noted that in the past
FDA Policy/General
Domestic sales and distribution of antimicrobials approved for use in food-producing animals decreased by 10% from 2015 through 2016, according to a Center for Veterinary Medicine (CVM) summary report. The summary report presents sales and distribution data for the 2016 calendar year for actively marketed antimicrobial drugs approved for
Drugs
FDA has issued a draft guidance, Pediatric Rare Diseases—A Collaborative Approach for Drug Development Using Gaucher Disease as a Model, to facilitate drug development in pediatric rare diseases. “In particular,” the document says, “it discusses a new possible approach to enhance the efficiency of drug development in pediatric rare
Drugs
FDA has released the FDA-483 issued following an 11/6-11/11 inspection at Glenmark Pharmaceuticals, a finished dosage manufacturer in Solan, Himachal Pradesh, India. Inspection observations were: * failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any
Drugs
FDA has approved a Novo Nordisk NDA for Ozempic (semaglutide) injection 0.5 mg and 1 mg, a once-weekly glucagon-like peptide receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes. The company says approval was based on
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Blood and Blood Components.” The document provides recommendations about the use of serological tests to reduce the risk of transmission of such infections in blood
Devices
A CDRH 11/30 Webinar reviewed key changes to the recently finalized guidance Unique Device Identification: Direct Marking of Devices. UDI (unique device identifier) program regulatory policy analyst Christina Savasaar said the agency received 17 comments on its draft guidance from external stakeholders and published the final guidance 11/17.
Drugs
Advocacy group Public Citizen has petitioned FDA to add cesium chloride to its 503A Category 2 list of bulk drug substances identified by the agency as presenting a significant safety risk in drug compounding. The group says FDA has dragged its feet in adding the drug to the listing, noting
Drugs
The FDA Toxicology Working Group has laid out its Predictive Toxicology Roadmap, a six-part framework for integrating predictive toxicology methods into safety and risk assessments of FDA-regulated products. FDA acting chief scientist Denise Hinton writes in an FDA Voice online post with Center for Food Safety and Applied
Drugs
FDA has granted full approval for Genentech’s Avastin (bevacizumab) for treating adults with glioblastoma that progressed following prior therapy. Avastin was previously approved under the agency’s accelerated approval program, which requires confirmatory evidence in order for it to be converted to full approval. The approval decision was based
FDA Policy/General
Federal Register notice: FDA has extended the comment period on a 9/8 notice seeking input on existing regulations and related paperwork requirements that could be modified, repealed, or replaced to achieve meaningful burden reduction. Comments now can be submitted until 2/5/2018. To view the notice, click here.
Drugs
FDA has accepted for review an Insys Therapeutics NDA for what it calls a novel formulation of buprenorphine as a sublingual spray for managing moderate-to-severe acute pain. The agency has set a user fee review target date of 7/28/2018. The submission is based primarily on a
Drugs
The Supreme Court has invited the Solicitor General to submit a brief outlining the views of the United States on Merck’s request that the high court hear its appeal of a 3rd Circuit court decision involving a state law failure-to-warn claim for the company’s Fosamax (alendronate
Devices
A 6/22-7/5 FDA inspection at Hand Biomechanics Lab, Sacramento, CA, found Medical Device Reporting and Quality System Regulation violations in the firm’s manufacturing of bone fixation fastener systems. An 11/16 Warning Letter says specific violations were: * failing to submit a report to FDA no later
Drugs
The Los Angeles Times says that researchers who evaluated four FDA programs designed to speed drug approval found that 105 drugs and biologics approved between 1/2012 and 12/2016 went through the approval process with one of four designations intended to speed the path to approval, while 69 medications