Drugs
CDER has released a “Quality Metrics Technical Conformance Guide” that is intended to serve as the reference for implementing its earlier draft FDA guidance on Request for Quality Metrics. “FDA expects that quality metrics calculated from data that it collects will provide objective measures that, when used with additional internal
Devices
Medifirst Solutions has filed a 510(k) for its Time Machine TTML-8102000 Laser Thermal Therapeutic Device, and it has responded to a CDRH request for more information. The request was for electrical and safety test data, the company says, adding that a response from FDA is expected in a
Drugs
The Bipartisan Policy Center has issued a new report on “Using Real-World Evidence to Accelerate Safe and Effective Cures” that offers recommendations for FDA to help advance medical innovation. “Real-world evidence can play a significant role in modernizing the drug approval process in the United States,” the report
Drugs
The American Society of Health-System Pharmacists (ASHP) has approved a policy that urges Congress to ban all direct-to-consumer (DTC) advertising of prescription drugs and medication-containing devices. The new policy, which was adopted earlier this month by the organization’s House of Delegates, is a reversal of
Drugs
Reform is needed so that more clinical research could be useful, according to Stanford University School of Medicine researcher John Ioannidis. Writing in the open access online journal PLOS Medicine, Ioannidis says that clinical research should be useful in that it should make a difference for health and disease outcomes
Drugs
FDA intends to issue its proposed regulations on the licensing of prescription drug wholesale distributors and third-party logistics providers by the end of this year, according to attorneys Kevin Madagan and Rebecca Dittrich (Reed Smith), writing online in a blog post. They base their prediction on information from an
Devices
FDA says that adverse event reports submitted several years late by Medtronic for its Infuse bone graft did not provide any new information and did not warrant enforcement action. The agency statement is in a seven-page response to questions posed 4/12 by Sen. Al Franken (D-MN). The
Drugs
FDA is planning a pilot program to test and evaluate a new Import Trade Auxiliary Communication System (ITACS) account management function. Currently, ITACS provides the import trade community with four functions: (1) The ability to check the status of FDA-regulated entries and lines, (2) the ability to submit entry
Drugs
The Massachusetts federal jury acquittal of former Warner Chilcott president W. Carl Reichel on charges of conspiring to pay kickbacks to doctors won’t stop the Department of Justice from trying to hold company executives accountable for wrongdoing, according to three Paul Hastings attorneys. Writing in an online blog post,
Drugs
By asking for the view of the Solicitor General on an appeal filed by both parties in the Amgen v. Sandoz biosimilar case, the Supreme Court has effectively delayed any decision on the appeal until at least October, once its new session opens. Three Fish & Richardson attorneys who have
Drugs
The Pharmaceutical and Research Manufacturers of America (PhRMA) is opposing for safety reasons a Senate bill that is intended to target abusive delay tactics used by brand drug makers to block entry of generic drugs. The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act would resolve brand companies’
Drugs
FDA has approved an Opko Health NDA for Rayaldee (calcifediol) as a treatment for secondary hyperparathyroidism in patients with Stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency. The submission was given a complete response letter (CRL) in March that cited manufacturing deficiencies at Opko’s third-
Devices
FDA has cleared a Roche 510(k) for its Elecsys Brahms PCT (procalcitonin) assay as a dedicated testing solution for people with severe sepsis or septic shock. “PCT is a sepsis-specific biomarker associated with bacterial infection and PCT levels in blood can aid clinicians in assessing the risk of
Drugs
FDA has approved an Allergan supplemental NDA for Avycaz (ceftazidime and avibactam) to include clinical data from a Phase 3 trial evaluating the drug’s use in combination with metronidazole for treating complicated intra-abdominal infections (cIAI) caused by designated susceptible microorganisms. The study showed that clinical cure rates at
FDA Policy/General
Federal Register Notice: FDA intends to conduct a pilot program to test and evaluate a new Import Trade Auxiliary Communication System (ITACS) Account Management function. The agency will need participation from a small group of filers, importers of record, and consignees, who will use the new ITACS Account Management function
FDA Policy/General
Federal Register Notice: FDA is making available its FDA Adverse Event Reporting System (FAERS) Regional Implementation Specifications for the International Conference on Harmonization (ICH) E2B(R3) Specification. It is making this document available to assist interested parties in electronically submitting individual case safety reports and attachments to CDER and CBER.
FDA Policy/General
Federal Register Notice: FDA is amending a 6/16 notice of meeting of the Pediatric Oncology Subcommittee to reflect a change in the Procedure portion of the document. The meeting is scheduled to discuss six products in various stages of development for adult cancer indications and the current unmet clinical
Drugs
Novartis says that a revised draft FDA guidance on assay development and validation for immunogenicity testing of therapeutic protein products largely focuses on developing and validating neutralizing antibody assays. “However,” it said in a comment letter, “an integrated assessment of immunogenicity, pharmacokinetics, and pharmacodynamics may be more appropriate since the
Drugs
Mylan president Rajiv Malik says Indian drug companies are becoming frustrated with FDA’s lack of transparency in the process for resolving enforcement actions after a number of 2015 enforcement actions stopped new product approvals at many facilities. In an interview with Bloomberg News, Malik said that “there’s a
Devices
Medical device consulting firm IMUA Services describes the five most common medical device wipeouts and how to avoid them. Using a surfing theme, the Carlsbad, CA, company identifies the mistakes as: * not conducting market research or not conducting enough research on who will use a product, how it is used,
Devices
The FDA Los Angeles District Office says that its evaluation of corrective actions taken by Advanced Sterilization Products, Irvine, CA, in response to a 3/12/10 Warning Letter indicates that the firm appears to have addressed the violations in the letter. “Future FDA inspections and regulatory activities will further
Drugs
As president Obama prepares to sign a bill into law that would reform how the government responds to Freedom of Information Act (FOIA) requests, FDA, for now, has lost a bid to withhold FOIA-requested internal records related to investigational drugs (ZMapp) used to treat Ebola victims. An Arizona federal