Devices
The FDA Microbiology Devices Panel of the Medical Devices Advisory Committee meets August 16 to consider over-the-counter diagnostic tests for detecting pathogens causing infectious diseases. An agency executive summary released in advance of the meeting says the panel will discuss the risks and benefits of OTC diagnostic tests
Drugs
An 8/4-8/14/15 FDA inspection at Adamson Analytical Laboratories, Corona, CA, identified significant violations of current good manufacturing practice regulations for finished pharmaceuticals, according to an 8/2 Warning Letter from the agency’s Los Angeles District Office. Specific violations and deviations included: * failing to exercise appropriate
Drugs
Attorneys Frank Sasinowski and Alexander Varond (Hyman, Phelps & McNamara) say that their analysis of the strength of scientific and clinical evidence for FDA’s 19 non-AIDS, non-cancer Subpart H approval determinations over the accelerated approval program’s 24 years shows that the agency “exercises extraordinary regulatory flexibility
Drugs
FDA has published a draft guidance on “Ulcerative Colitis: Clinical Trial Endpoints” that is intended to assist sponsors in their clinical development of drugs for treating the condition in adult and pediatric patients. The document addresses FDA’s current thinking on efficacy endpoints for ulcerative colitis clinical trials. “This draft
Devices
A new report indicates that many medical device makers are not ready to implement Unique Device Identification (UDI) labeling based on FDA compliance deadlines. For example, next month the labels and packages of Class 2 devices must bear a UDI, according to the agency. However, the report from Loftware and
Drugs
FDA has granted Merck accelerated approval for Keytruda (pembrolizumab), an anti-PD-1 (programmed death receptor-1) therapy for patients with recurrent or metastatic head and neck squamous cell carcinoma with disease progression on or after platinum-containing chemotherapy. The approval was based on tumor response rate and durability of
Drugs
FDA has cited Alfred I. duPont Hospital for Children after an inspection of its sterile drug compounding operations found significant GMP violations. A just-posted Form 483 said the inspection found that the hospital aseptic processing areas’ systems for maintaining any equipment are deficient. Specifically, it says the hospital’s
Drugs
Improved research and technology development, combined with general advances in biological and information technologies, should accelerate improvement in cardiovascular outcomes, opines FDA commissioner Robert Califf in an 8/8 Journal of the American College of Cardiology article. “But if we are to harness these technologies and apply them effectively, our
Drugs
FDA has issued Alexion Pharmaceutical a three-item Form-483 after inspecting its Smithfield, RI manufacturing facility. “These observations are inspectional, and do not represent a final FDA determination of compliance,” the company said in a financial disclosure filing. “The observations pertain to: completion and closure of certain investigations, validation
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information, “Survey of Alumni Commissioner's Fellowship Program Fellows,” has been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995. The information from Alumni CFP Fellows will allow FDA’s Office
FDA Policy/General
Federal Register Notice: FDA has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements. The
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance for industry entitled Ulcerative Colitis: Clinical Trial Endpoints. It aims to assist sponsors in the clinical development of drugs for treating ulcerative colitis (UC) in adult and pediatric patients and addresses FDA’s current thinking on efficacy endpoints for UC
FDA Policy/General
Federal Register Notice: FDA is making available the draft guidance entitled Deciding When to Submit a 510(k) for a Software Change to an Existing Device. It is aiming to clarify when a software change in a legally marketed medical device would require that a manufacturer submit a premarket notification
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance entitled Deciding When to Submit a 510(k) for a Change to an Existing Device. FDA intends to clarify when a change in a legally marketed medical device would require that a manufacturer submit a premarket notification (510(k)) to
FDA Policy/General
Federal Register Notice: FDA is reopening the comment period on the potential development of a user-fee program for nonprescription (over-the-counter) monograph drugs. The agency sought comments in the 5/11 Federal Register that announced a 6/10 public meeting on the topic. FDA will hold a Webinar
FDA Policy/General
Federal Register Notice: FDA is completing the target of the goal established to address CDRH’s 2014-2015 Strategic Priority “Strike the Right Balance Between Premarket and Postmarket Data Collection.” To achieve this strategic priority, CDRH established a goal to facilitate and expedite the development and review of medical devices,
FDA Policy/General
Federal Register Proposed rule/direct final rule: FDA is issuing a proposed rule describing when it would refuse to accept a tobacco product submission (or application) because the application has not met a minimum threshold for acceptability for agency review. Under the proposed rule, FDA would refuse to accept a
Drugs
The National Institutes of Health Clinical Center has “decommissioned” operations at its Pharmaceutical Development Section (PDS) after “serious manufacturing problems and lack of compliance with standard operating procedures” were uncovered in an FDA inspection last year. Previously, PDS operations were suspended while corrective actions were taken (see earlier story). PDS
Devices
A California state court has allowed a series of product liability lawsuits to proceed against Bayer by 14 women who allege that they have been injured by the company’s birth control device Essure. The suits contend that the device can come out of place and puncture the uterus, and
FDA Policy/General
Federal Register Direct final rule: FDA is confirming the effective date of 9/16 for the 5/4 final rule that amends the general biological products standards relating to dating periods and removes certain standards relating to standard preparations and limits of potency. The agency aims to update outdated requirements,
FDA Policy/General
BIOLOGICS Guidance on Blood Donors for Autologous Use Federal Register Notice: FDA is making available a document entitled Determining Donor Eligibility for Autologous Donors of Blood and Blood Components Intended Solely for Autologous Use — Compliance Policy; Guidance for Industry. This guidance addresses the regulatory requirements for determining donor eligibility that
FDA Policy/General
Fe3 Medical, an InCube Labs company says the state of Texas has invested $3.5 million as part of an extension to the company’s Series B round to be used for product development, clinical trials and regulatory submissions required to obtain FDA approval for the transdermal patch for patients