Drugs
The Generic Pharmaceutical Association says that it agrees with FDA that data should be reliable and accurate. “Good manufacturing practices must be followed and data integrity is a necessary component of a robust quality system,” it says in commenting on an agency draft guidance on data integrity and compliance with
Drugs
FDA has released a draft guidance on “Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in FDA Advisory Committees” that addresses the process for evaluating whether an advisory committee member has potentially disqualifying non-financial interests or relationships. It also describes FDA’s process for determining whether to
Drugs
Should FDA be allowed to accept gifts from any source on behalf of the United States? A new draft guidance on “Gifts to FDA: Evaluation and Acceptance” provides the process and principles the agency will use to implement this authority, recently delegated to it by HHS. The guidance is open
FDA Policy/General
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Coastal Meds, LLC Biloxi, MS (6/22). Inspected 9/15-23/15. CGMP deviations, adulterated, misbranded, unapproved new drug products: The FDA investigator observed serious deficiencies in the firm’
Devices
FDA has cleared a QT Vascular 510(k) for the Chocolate XD PTCA catheter for balloon dilatation of the stenotic portion of coronary artery or bypass graft stenosis for improving myocardial perfusion, including in-stent restenosis. The device uses a “nitinol constraining structure that is mounted on a semi-compliant
Drugs
FDA has placed a clinical hold on a Regulus Therapeutics IND for RG-101 for treating chronic hepatitis C virus (HCV) infection after the company reported a second serious adverse event involving jaundice. The event occurred in a HCV patient with end-stage renal disease on dialysis who was enrolled
Biologics
Despite a recommendation by a CDC panel that MedImmune’s FluMist live attenuated influenza vaccine should not be used during the 2016-2017 flu season because new preliminary data questioned its effectiveness rate, FDA says it has decided to leave the product on the market and no further regulatory action
Drugs
Esperion Therapeutics says it plans to start global pivotal Phase 3 efficacy and safety studies of its bempedoic acid for lowering low density lipoprotein cholesterol (LDL-C) in the fourth quarter of this year, along with a global cardiovascular outcomes trial in patients with elevated LDL-C levels who are
Drugs
House Energy and Commerce Committee chairman Fred Upton (R-MI) and Health Subcommittee chairman Joseph Pitts (R-PA) have written FDA seeking answers about its procedures for protecting product trade secret and confidential information in the wake of a recent insider trading scandal involving the Office of Generic Drugs. Earlier
FDA Policy/General
A panel of six former FDA commissioners, who combined have 32 years of FDA leadership experience, told an Aspen Institute/Atlantic magazine conference 6/25 they strongly believe the agency should be independent and not housed under Health and Human Services, and that it should operate under a model used
Drugs
A recent FDA inspection of hospice pharmacy service-provider Enclara Pharmacia (Sharon Hill, PA) resulted in a two-page Form 483 that cited the firm’s aseptic processing and its system for monitoring environmental conditions during sterile drug production. Specifically, environmental monitoring of surfaces for microbial contamination is not performed
FDA Policy/General
Federal Register Notice: FDA is extending the comment period for a 5/4 notice of availability of the draft guidance for industry entitled Special Protocol Assessment. FDA is taking this action due to maintenance on the Federal eRulemaking portal from 7/1-7/5. Comments should be submitted by 7/
FDA Policy/General
Federal Register Notice: FDA is making available a Technical Specifications Document entitled “Quality Metrics Technical Conformance Guide, Version 1.0.” It provides technical recommendations for the submission of quality metric data. It serves as the technical reference for implementation of the draft FDA guidance for industry when finalized, Request for
FDA Policy/General
Federal Register Notice: FDA is making available a publication containing modifications it is making to the list of standards that the agency recognizes for use in premarket device reviews. This publication, entitled “Modifications to the List of Recognized Standards, Recognition List Number: 043,” will assist manufacturers who elect to declare
FDA Policy/General
Federal Register Notice: FDA is extending the comment period for a 5/4 notice of availability of the draft guidance for industry entitled Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment. FDA is taking this action due to maintenance on the Federal eRulemaking portal from 7/
Drugs
A Project HOPE Health Affairs blog post offers recommendations that it says FDA should accept in order to address certain ethical issues around the expedited approval of new prescription drugs. An expedited drug enters clinical practice without the same amount or quality of supporting data as one traditionally approved by
FDA Policy/General
A new report by OpenTheBooks.com examines the purchases of weapons federal agencies, including FDA. “Regulatory enforcement within administrative agencies now carries the might of military-style equipment and weapons, according to the report, The Militarization of America: Non-Military Federal Agencies Purchases of Guns, Ammo, and Military-Style Equipment.
Devices
CDRH and the medical device industry are exploring the addition of more resources and performance goals under the next Medical Device User Fee Program to improve the Center’s Pre-Submission (Pre-Sub) process. In just-released user fee negotiation meeting minutes, FDA explained that the Pre-Sub consultation process
FDA Policy/General
BIOLOGICS FDA Withdraws Notice on Biological Product Naming Federal Register Withdrawal of notice: FDA withdraws a 6/2 Federal Register notice, which announced that a proposed collection of information, “Guidance for Industry on Nonproprietary Naming of Biological Products,” had been submitted to the Office of Management and Budget. To view
Biologics
Rep. Jan Schakowsky (D-IL) and Sens. Sherrod Brown (D-OH) and John McCain (R-AZ) have introduced the “Price Relief, Innovation and Competition for Essential Drugs (PRICED) Act” that they say would foster competition and provide opportunity for more biologics to enter the marketplace and drive down costs. “In
Biologics
When FDA declares a therapy safe and effective for its labeled indication, what happens when a sister agency — in this case, the Centers for Disease Control and Prevention (CDC) — subsequently declares it ineffective for that indication and recommends use of a different product instead? That’s what happened 6/23
Biologics
FDA has approved a Protein Sciences BLA supplement to extend the shelf life for Flublok, its seasonal influenza vaccine. The shelf life has been extended to nine months from the date of manufacture — increasing the previous shelf life by three months. The longer shelf life is intended to help healthcare