Devices
FDA has cleared a Toshiba Medical 510(k) for the Forward Projected Model-based Iterative Reconstruction Solution (FIRST) that is intended to improve high contrast spatial resolution while reducing radiation dose up to 85% as compared to filtered back projection computed tomography imaging. “FIRST can improve high-contrast spatial resolution
Drugs
Public Citizen and seven other consumer and government watchdog groups have told FDA that its draft guidance on “Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in FDA Advisory Committees” would allow the agency to continue inappropriately excluding advisory committee members from participating in committee meetings. The groups
FDA Policy/General
Federal Register Notice: FDA has announced that OMB has approved an information collection on “Abbreviated New Drug Applications and 505(b)(2) Applications.” The information collection is related to a 10/6 final rule that implemented Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA)
FDA Policy/General
Federal Register Notice: FDA has asked for comments on an information collection extension on its guidance for “Expedited Programs for Serious Conditions — Drugs and Biologics. The guidance outlines the programs’ policies and procedures and describes applicable threshold criteria, including when to submit information to FDA. To view the notice, click
FDA Policy/General
Federal Register Notice: FDA is seeking comments on a new direct-to-consumer (DTC) study proposal submitted to OMB for approval on Superimposed Text in DTC Promotion of Prescription Drugs. The proposed study seeks to extend previous research on the effects of superimposed text in advertising to today’s modern
Drugs
Federal Register Notice: FDA has extended the comment period on a 9/14 notice on the establishment of appropriately targeted durations of use of antimicrobial drugs of importance to human medicine (i.e., medically important antimicrobial drugs) when they are administered in the feed or water of food-producing animals
FDA Policy/General
Federal Register Notice: FDA has announced a 3/15/2017 Pharmaceutical Science and Clinical Pharmacology Advisory Committee that will discuss the use of model-informed drug development (MIDD) for new and generic drugs, which has significantly increased over the past several years. The committee will discuss strategies, approaches, and challenges
FDA Policy/General
DEVICES FDA has approved Medtronic’s Claria MRI Quad Cardiac Resynchronization Therapy Defibrillator (CRT-D) SureScan device for patients with heart failure. The device is approved for scanning in both 1.5 and 3 Tesla magnetic resonance imaging machines, and features EffectivCRT, a new algorithm that personalizes therapy to individual
Drugs
FDA has published a draft guidance, Submission of Quality Metrics Data, explaining and implementing the voluntary reporting phase of its new quality metrics reporting program. The document says that CBER and CDER will use submitted data and quality metrics to help ensure that their policies and practices continue to support
FDA Policy/General
Federal Register Notice: FDA has made available a guidance entitled “Contract Manufacturing Arrangements for Drugs: Quality Agreements.” The document describes FDA’s current thinking on defining, establishing, and documenting manufacturing activities of the parties involved in contract drug manufacturing subject to current GMP requirements. Specifically, it describes how parties involved
Drugs
Juno Therapeutics is facing another setback on pushing its CAR-T cell product candidate through the development process after the company placed its ROCKET trial on clinical hold following cerebral edema reported in two patients earlier this week. One patient died and the other is not expected to recover. In
Biologics
FDA has issued Green Cross Corp. a complete response letter on its BLA for IVIG-SN (human normal immunoglobulin G for intravenous administration), intended for treating primary immunodeficiency diseases. The letter asks for additional information related to chemistry, manufacturing and controls, according to the company, and it did not cite
Drugs
CDER director Janet Woodcock says that clinical trial designs, no matter how novel, “will only be as good as the knowledge that underlies them.” In presentation slides prepared for the 12th annual personalized medicine conference, she says that the full clinical development program must be considered, and not just the
FDA Policy/General
Federal Register Final Rule: FDA has amended its nonprescription (over-the-counter or OTC) drug regulations to supplement the time and extent application (TEA) process by establishing timelines and performance metrics for FDA’s review of non-sunscreen TEAs, as required by the Sunscreen Innovation Act. It also amends the
FDA Policy/General
Federal Register Notice: FDA has made available a guidance entitled “Nonprescription Sunscreen Drug Products — Format and Content of Data Submissions.” The document provides FDA’s current thinking on the format and content of information provided to support a request for a determination whether a nonprescription sunscreen active ingredient is generally
FDA Policy/General
Federal Register Notice: FDA has made available a guidance on “Nonprescription Sunscreen Drug Products — Safety and Effectiveness Data.” The document addresses the agency’s thinking about data needed to determine whether a nonprescription over-the-counter sunscreen ingredient or combination of ingredients evaluated under the Sunscreen Innovation Act is generally
Drugs
Eli Lilly says solanezumab did not meet the primary endpoint in the EXPEDITION3 clinical trial, a Phase 3 study in people with mild dementia due to Alzheimer’s disease. “Patients treated with solanezumab did not experience a statistically significant slowing in cognitive decline compared to patients treated with placebo (p=
Drugs
FDA has issued a guidance, Contract Manufacturing Arrangements for Drug: Quality Agreements, with the agency’s current thinking on defining, establishing, and documenting manufacturing activities of the parties involved in contract drug manufacturing subject to current good manufacturing practice requirements. In particular, the document says, “we describe how parties involved
Drugs
FDA has denied in part a Therapeutic Proteins International petition asking that it take actions to advance the use of risk-based bioequivalence testing. To the extent that the petition asks the agency to undertake activities it is already doing, the letter says, it is granted. The 2007 petition called
FDA Policy/General
President-elect Donald Trump met with Indiana state health commissioner Jerome Adams on 11/21, presumably as a candidate for HHS secretary or another health-related position in the new administration. They discussed establishing better doctor–patient relationships, healthcare challenges Americans face each day with Obamacare, and ideas for enacting
Drugs
Intarcia Therapeutics has submitted an NDA for ITCA 650 (exenatide) for treating Type 2 diabetes. If approved, the drug would become the first injection-free glucagon-like peptide-1 (GLP-1) receptor agonist therapy. It is designed to provide consistent and continuous subcutaneous delivery of exenatide via an osmotic mini-
FDA Policy/General
Federal Register Notice: FDA has determined the regulatory review period for Medtronic’s Core Valve System for patent extension purposes — 1,194 days. Of this time, 1,017 days occurred during the testing phase of the regulatory review period, while 177 days occurred during the approval phase. To view the