Drugs
FDA has granted HedgePath Pharmaceuticals an orphan drug designation for SUBA-itraconazole capsules for treating patients with Basal Cell Carcinoma Nevus Syndrome (BCCNS) with its oral formulation of SUBA-Itraconazole capsules. BCCNS results from a genetic mutation that causes the Hedgehog pathway to function improperly, leading to the chronic formation
FDA Policy/General
Federal Register Notice: FDA has released a guidance on “Individual Patient Expanded Access Applications: Form FDA 3926.” The document describes the process for licensed physicians to request expanded access for individual patients. The form provides a streamlined alternative for submitting requests for individual patient expanded access, including for emergency use.
FDA Policy/General
Federal Register Notice: FDA has announced a 6/23 Pharmacy Compounding Advisory Committee meeting at its White Oak campus to discuss six bulk drug substances nominated for inclusion on the agency’s bulk drug substances list: chrysin, cesium chloride, sodium dichloroacetate, pyruvic acid, tea treeoil, and 2,3-Dimercapto-1-
FDA Policy/General
Federal Register Notice: FDA has published a guidance on “Expanded Access to Investigational Drugs for Treatment Use — Questions and Answers.” The guidance provides information about implementing regulations on expanded access to investigational drugs for treatment use. FDA received a number of questions concerning implementation of its expanded access regulations and
Drugs
Sens. Michael Bennet (D-CO) and Orrin Hatch R-UT) say they will attach their bill to create a new antibiotic drug approval pathway as an amendment to the National Defense Authorization Act for Fiscal Year 2017. Their Promise for Antibiotics and Therapeutics for Health (PATH) act would permit FDA
Drugs
FDA has issued a draft ICH harmonized guidance, E18 Genomic Sampling and Management of Genomic Data, that to provide harmonized principles of genomic sampling and management of genomic data in clinical studies. The document is intended to facilitate genomic studies implementation by enabling a common understanding of critical parameters for
Biologics
A coalition of 10 patient advocacy and research groups, including the Cystic Fibrosis, Muscular Dystrophy and National Patient Advocate foundations, the National MS Society, and the National Organization for Rare Disorders, say they oppose provisions in the Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW Act)
FDA Policy/General
Federal Register Notice: FDA has submitted to OMB for clearance a proposed collection of information contained in the agency’s guidance on “applicants propose a suffix composed of four lowercase letters for use as the distinguishing identifier included in the proper name designated by FDA at the time of licensure.
FDA Policy/General
Federal Register Notice: FDA’s Philadelphia District Office and the Association of Food and Drug Officials are co-sponsoring a conference on “Collaborating to Strengthen Food, Drug, and Medical Device Safety Systems.” This conference is intended to provide information about FDA drug and device regulation to regulated industry. will be
Drugs
FDA says it is investigating reports of serious burns and potential permanent scarring in users of NuPathe’s battery-powered Zecuity (sumatriptan iontophoretic transdermal system) patch, indicated for treating acute migraines with or without aura in adults. “We are investigating the cause and extent of these serious side effects and
Drugs
FDA has granted Viamet Pharmaceuticals fast track status for VT-1129 for treating cryptococcal meningitis, a life-threatening fungal infection of the membranes covering the brain and spinal cord. Previously, the inhibitor of fungal CYP51 received orphan drug and qualified infectious disease product designations from the agency. Cryptococcal meningitis is
Devices
The average time for FDA to review and make a decision on 510(k)s dropped to 122 days in FY 2015, which is five days faster than 2014, and 23 days (16%) faster than in 2012 when it took 145 days, according to just-released medical device user fee
Drugs
In an effort to streamline the process doctors use to request expanded access (compassionate use) to investigational drugs and biologics for specific patients, FDA has released a new, much shorter Individual Patient Expanded Access Investigational New Drug Application, that the agency says should only take doctors 45 minutes to complete.
Drugs
Two researchers who were on the Institute of Medicine’s Committee on Policy Issues in the Clinical Development and Use of Biomarkers for Molecularly Targeted Therapies say there are steps that should be taken to improve the usefulness of biomarkers as part of precision medicine. Writing in a New England
Drugs
Attorney James Beck (Reed Smith) says that FDA’s extension of the comment period for its proposed generic drug labeling rule until 4/2017, after the upcoming presidential election, means that “for all practical purposes … the proposed rule is dead.” In an online blog post, Beck says that the law
Drugs
The AIDS Healthcare Foundation (AHF) says that FDA and Congress should investigate AIDS drug manufacturer Gilead Sciences for potential patent manipulation and antitrust violations. AHF says the company demonstrated “bald-faced greed” and “disregard for patient safety” in its development of TAF (tenofovir alafenamide fumarate), which can work at a
FDA Policy/General
Federal Register Notice: FDA has published a draft guidance on “Assessing Adhesion with Transdermal Delivery Systems and Topical Patches for ANDAs.” The document provides recommendations for study design and conduct when evaluating the adhesive performance of a transdermal delivery system or a topical patch that will support an ANDA submission.
FDA Policy/General
Federal Register Notice: FDA is holding a public workshop entitled: “OpenFDA Public Workshop.” The workshop is intended to provide a forum for the openFDA system user community to discuss and provide feedback on the platform, application programming interfaces, downloadable harmonized datasets, and possible enhancements. The workshop will be held 6/
FDA Policy/General
Federal Register Notice: FDA has published a draft guidance on “FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions.” The document modifies FDA’s current policy on categorization of IDE devices, which assists CMS in determining whether an
Devices
FDA has approved Roche’s cobas EGFR Mutation Test v2, a companion diagnostic for the cancer drug Tarceva (erlotinib) that is the first blood-based genetic test detect epidermal growth factor receptor (EGFR) gene mutations in non-small cell lung cancer patients, according to an agency release. “With the cobas
Biologics
FDA has asked the Office of Management and Budget to approve an information request outlined in a 2015 draft guidance on Nonproprietary Naming of Biological Products that would have biologic and biosimilar product sponsors submitting proposed suffixes to be incorporated in the nonproprietary name on such products (see story). According
Drugs
CDER Office of Compliance manufacturing quality guidance and policy staff director Paula Katz says that three key elements in a drug company’s response to a data integrity Warning Letter are a comprehensive evaluation, risk assessment, and remediation and a management strategy. Speaking at a Parenteral Drug Association Manufacturing Science