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 A new draft guidance on “Gifts to FDA: Evaluation and Acceptance” provides the process and principles the agency will use to implement this authority, recently delegated to it by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
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
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
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
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
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
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-
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
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
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
Drugs
FDA says its FDA Adverse Event Reporting System regional implementation specifications developed for the International Conference on Harmonization are now available. A 6/23 Federal Register notice containing a link to the guidance says that the agency is making the technical specifications document available to assist interested parties in electronically