Drugs
FDA has released a draft guidance, Draft Guidance on Fluticasone Propionate, that recommends in vitro and in vivo studies to establish bioequivalence of the test and reference metered dose inhalers containing fluticasone propionate. For in vitro studies, the document recommends that studies be conducted for all strengths of the test
Drugs
An Illinois federal court has entered a permanent injunction against three related Chicago companies — Global Marketing Enterprises, Lifeline Nutrients Corp., and Pronto Foods Company — and their owner Eduardo Chua and operations manager Haidee Dawis. The Justice Department says the injunction prevents the defendants from manufacturing, selling, and distributing adulterated and
Drugs
FDA has accepted for review an EMD Serono NDA resubmission for cladribine tablets for treating patients with relapsing forms of multiple sclerosis (MS). The resubmission addresses a 2011 complete response letter requesting an improved understanding of safety risks and the overall benefit-risk profile. The letter said the company’s
Drugs
The initial and annual biologic product development fee for FY 2019 under the Biosimilar User Fee Amendments of 2017 will be $189,405, according to a fee schedule released by FDA. A Federal Register notice to be published 7/31 also lists the reactivation fee as $370,818, for an
Drugs
FDA says it has found that several additional drug repackagers are recalling valsartan-containing products. In its latest product recall update, the agency says it has recall information from three additional repackagers of valsartan-containing products made by Teva and Prinson, labeled as A-S Medication Solutions, AvKARE, and RemedyRepack.
Drugs
Reps. Jan Schakowsky (D-IL) and Francis Rooney (R-FL) say they have come together as bipartisan House sponsors of the FAIR (Fair Accountability and Innovative Research) Drug Pricing Act that would require drug companies to give notice and justification for raising the price of a drug. The bill already
Drugs
Ranier’s Rx Laboratory has recalled all sterile compounded drug products within expiry to the hospital or consumer level due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile. The concerns were raised during a
Drugs
FDA has approved Progenics Pharmaceuticals’ Azedra (iobenguane) injection for IV use to treat adults and adolescents age 12 and older with pheochromocytoma or paraganglioma tumors that are unresectable, have spread beyond the original tumor site, and require systemic anticancer therapy. An agency statement says this is the first FDA-approved
Drugs
Rep. Jan Schakowsky (D-IL) has introduced a suite of bills intended to lower prescription drug prices. Included were: * H.R. 6574—the Medicare Fair Drug Pricing Act that she says would lower prescription drug prices for Medicare beneficiaries by allowing the HHS secretary to negotiate the price for the
Drugs
FDA has accepted for review a Nektar Therapeutics NDA for NKTR-181 for treating chronic low back pain in adult patients new to opioid therapy. The new molecular entity is the first analgesic opioid molecule to exhibit a low incidence of specific central nervous system-mediated side effects, such as
Drugs
FDA has issued INSYS Therapeutics a complete response letter for its buprenorphine sublingual spray as a treatment for moderate-to-severe acute pain. The letter adheres to an advisory committee vote in May and “indicates that, although the clinical development program demonstrated all three proposed doses of the product candidate
Drugs
FDA has published a draft guidance, Slowly Progressive, Low-Prevalence Rare Diseases with Substrate Deposition That Results from Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies, to give guidance to sponsors on the evidence necessary to demonstrate the effectiveness of new drugs or new drug uses
Drugs
CDER director Janet Woodcock and CDER Office of Pharmaceutical Quality director Michael Kopcha say FDA has responded to stakeholder requests for continued dialog on quality metrics with two new voluntary programs. Writing in an FDA Voice blog post, the two say that the programs are the Quality Metrics Feedback Program
Drugs
Regulatory consulting firm Greenleaf Health has added former FDA field investigator Kristen Grumet as senior vice president for regulatory compliance. Grumet spent almost 10 years at the agency and focused on medical device compliance. She also has 16 years of quality systems compliance management and consulting within the device industry.
Drugs
Attorney Jennifer Davidson (Kleinfeld, Kaplan & Becker) says an FDA 7/18 draft question-and-answer guidance on field alert report (FAR) submissions clarifies the circumstances under which a FAR should be submitted. FDA regulations says a FAR should be submitted to the agency within three working days of receipt
Drugs
FDA says it has finalized a guidance, Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases. A Federal Register notice scheduled to be published 7/27 says the agency does not expect to grant any additional orphan drug designation to drugs for pediatric subpopulations of
Drugs
FDA’s Pulmonary Allergy Drugs Advisory Committee has voted 16 to 3 against approving the use of GlaxoSmithKline’s mepolizumab as an add-on treatment to inhaled corticosteroid-based maintenance treatment for reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) guided by blood eosinophil counts. The committee said
Drugs
Public Citizen says FDA and the HHS Office for Human Research Protections (OHRP) should immediately investigate two prospective clinical trials in Minnesota that involved testing the general anesthetic ketamine and powerful sedatives on patients without their consent. The advocacy group was joined by 64 doctors, bioethicists, and academics in the
Drugs
The Supreme Court has agreed to hear Merck’s appeal of a controversial 3rd Circuit Court of Appeals ruling that a jury should be allowed to “speculate” about how FDA might have responded to a hypothetical Merck application to add to its Fosamax label a warning about atypical femur fracture.
Drugs
CDER has issued a Manual of Policies and Procedures (MAPP) outlining the process CDER review staff follows when (1) selecting or creating an established pharmacologic class text phrase that will be associated with an approved indication and included under the Indications and Usage section of labeling; and (2) assigning clinically
Drugs
Agile Therapeutics says it will appeal to the CDER Office of New Drugs the decision by the Office of Drug Evaluation 3 (ODE3) director to deny its appeal of a Division of Bone, Reproductive, and Urologic Products complete response letter for its NDA for Twirla (levonorgestrel/ethinyl/estradiol transdermal system)
Drugs
FDA commissioner Scott Gottlieb says more focus is being placed on modernizing clinical trials. Testifying at a House Energy and Commerce Subcommittee hearing 7/25, Gottlieb said that the use of surrogate endpoints is getting much attention. He said that the agency had just released a list of biomarkers that