Drugs
A briefing document prepared for a joint advisory committee meeting that voted 10-9 to recommend removal of a Boxed Warning for Pfizer’s Chantix relating to potential psychiatric risks, including suicide and suicidal ideation, raised CDER medical reviewer concerns that data from a company post-marketing study were biased
Devices
FDA has cleared a Life Spine 510(k) for the PRO-LINK Ti Stand-Alone Cervical Spacer System, a stand-alone cervical interbody that is made using the company’s Osseo-Loc technology. Osseo-Loc is a proprietary surface treatment for titanium with 500-600 microns of porosity, which is
Drugs
FDA has accepted for review a Puma Biotechnology NDA for its lead product candidate PB272 (neratinib), indicated for the extended adjuvant treatment of patients with early stage HER2-overexpressed/amplified breast cancer who have received prior adjuvant trastuzumab (Herceptin)-based therapy. The submission is based on data from the ExteNET
FDA Policy/General
Federal Register Notice: FDA’s Risk Communication Advisory Committee has planned an 11/7 meeting to discuss and make recommendations on the agency’s draft “Strategic Plan for Risk Communication and Health Literacy.” The plan is intended to clarify how the agency can communicate the benefits and risks of FDA-
FDA Policy/General
Federal Register Notice: FDA is announcing the 2016 FDA Naloxone App Competition, a prize competition designed to help reduce deaths associated with prescription opioid and heroin overdose by seeking innovative approaches to help reduce preventable harm associated with the drugs. The goal is to spur innovation around the development of
Drugs
CDER director Janet Woodcock had made up her mind to approve (see earlier story) Sarepta’s controversial Duchenne drug Exondys 51 (eteplirsen) well before the Center review team had completed its review — in fact, she had written an approval memo before reviewers even submitted their review memo and summary. This
Drugs
KemPharm has decided to file a formal dispute resolution request over a June FDA complete response letter on an NDA label claim of abuse deterrence for Apadaz (benzhydrocodone and acetaminophen), an investigational abuse-deterrent product candidate for the short-term management of acute pain. The company expects it could take
Devices
FDA has approved a Med-El USA PMA for the Synchrony EAS (Electric Acoustic Stimulation) Hearing Implant System. The device combines two technologies — a Synchrony cochlear implant that stimulates the auditory nerve for high-frequency hearing loss, and the Sonnet EAS audio processor, with built-in acoustic amplification for low-
Drugs
FDA has announced a Naloxone App Competition, a public contest focused on developing a mobile phone application that can connect opioid users experiencing an overdose with nearby carriers of the prescription drug naloxone – the antidote for an opioid overdose. The contest builds on work announced in the agency’s Opioids
FDA Policy/General
Federal Register Notice: FDA is seeking comments on abuse potential, actual abuse, medical usefulness, trafficking, and impact of controlled substance scheduling changes on availability for medical use of 12 drug substances. The comments will be considered in preparing a response from the U.S. to the World Health Organization (W.
FDA Policy/General
Federal Register Notice: FDA has established a docket to receive suggestions, recommendations, and comments on a list of biomarkers that were used as outcomes to develop FDA-approved new molecular entities and biological therapeutics from 2007 to 2015. Comments received on the list will help FDA determine the utility of
FDA Policy/General
Federal Register Notice: FDA is publishing a notice that an applicant for a proposed biosimilar product notified the agency that a patent infringement action was filed in connection with the applicant’s biologics license application. Under the Public Health Service Act, a biosimilar applicant must notify FDA within 30 days
FDA Policy/General
Federal Register Notice: FDA is seeking public comments on a proposed collection of certain information to support social and behavioral research used by the agency about drug products. The agency is interested in obtaining data to understand patients, consumers and health care professionals’ perceptions and behaviors in order to improve
FDA Policy/General
Federal Register notice: FDA is posting a draft guidance entitled “S9 Nonclinical Evaluation for Anticancer Pharmaceuticals—Questions and Answers” that provides recommendations for nonclinical studies for the development of pharmaceuticals intended to treat patients with cancer. To view this guidance, click here. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA has announced a public meeting entitled “Health Canada and FDA Joint Public Consultation on International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).” The meeting will provide information and receive comments on the current activities of ICH, as well as the upcoming
Drugs
FDA has told Teva Pharmaceutical Industries that a previously agreed to Special Protocol Assessment (SPA) has been rescinded for the Phase 3 CONCERTO clinical trial evaluating laquinimod in relapsing remitting multiple sclerosis (MS). Earlier this year, Teva and its development partner Active Biotech confirmed that the highest dose arms in
Devices
FDA has approved Bayer’s Kyleena (levonorgestrel-releasing intrauterine system) 19.5 mg, a progestin-containing intrauterine system for preventing pregnancy for up to five years. Kyleena is a small, flexible plastic T-shaped device containing levonorgestrel 19.5 mg. It is placed by a healthcare provider during an in-
FDA Policy/General
Federal Register Notice. FDA is announcing a public meeting to discuss proposed recommendations for reauthorizing the Biosimilar User Fee Act (BsUFA) for fiscal years 2018 through 2022. FDA will consider the public views and comments from this meeting to revise the recommendations as necessary. The public meeting will be held
FDA Policy/General
Federal Register Notice: FDA is announcing a public meeting entitled “Progress Toward Implementing the Product Identification Requirements of the Drug Supply Chain Security Act.” The meeting is intended to provide members of the pharmaceutical distribution supply chain and other stakeholders an opportunity to share information with the agency about the
Drugs
After surviving an internal staff challenge adjudicated in her favor by FDA commissioner Robert Califf, CDER director Janet Woodcock made final her decision to approve Sarepta Therapeutics’ Duchenne muscular dystrophy (DMD) drug Exondys 51 (eteplirsen) under the agency’s accelerated approval process 9/19. It’s unprecedented for such a
FDA Policy/General
ANIMAL DRUGS Guidance on Animal Drug Bioequivalence Waivers Federal Register Notice: FDA has made available a revised guidance for industry (#171) on “Waivers from the Requirement to Demonstrate Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles.” The document describes how CVM intends
Drugs
FDA has posted an International Conference on Harmonization draft guidance on “S9 Nonclinical Evaluation for Anticancer Pharmaceuticals — Questions and Answers” that is intended to help sponsors implement the S9 Guideline to reduce/replace the use of animals in preclinical studies. For example, where a therapeutic increases survival, “no additional general