Drugs
The DC federal court says FDA misinterpreted the Federal Food, Drug, and Cosmetic Act (FFDCA) when it approved Lannett’s Numbrino (cocaine HCl) nasal solution during the period of Genus Lifesciences’ five-year new chemical entity exclusivity for Goprelto (cocaine HCl) nasal solution. Genus filed suit after the agency approved
Drugs
FDA has announced a 10/30 virtual public workshop on “New Drugs Regulatory Program Modernization: Implementation of the Integrated Assessment of Marketing Applications and Integrated Review Documentation.” The event is intended to solicit public feedback on characteristics of the integrated review document and how the integrated assessment can continue to
Drugs
The Alliance for Regenerative Medicine says CBER was under-represented in an independent third-party review assessment of FDA-sponsor communication practices during the IND stage of new drug/biologic development. The group says that “in light of the resource constraints and staggering number of active INDs with CBER,” FDA
FDA Policy/General
An Axios/Ipsos poll conducted on 9/11-9/14 finds that fewer than 10% of Americans have a great deal of trust in FDA or in drug companies to look out for their interests. The firms say the poll results show how difficult it may be to get Americans
Drugs
A 2/10-2/21 FDA inspection at Kalchem International, Lindsay, OK, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and significant deviations from CGMP for active pharmaceutical ingredients (API). An 8/27 Warning Letter says specific issues were: * failing to have, for each batch
Drugs
FDA has published a draft guidance, Geriatric Information in Human Prescription Drug and Biological Product Labeling, to assist applicants in determining the appropriate placement and content of geriatric information in labeling as described in the regulations for the content and format of labeling for human prescription drug and biological products.
Drugs
A 2/17-2/20 FDA inspection at the Mayon’s Pharmaceuticals facility in Nagpur, Maharashtra, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and significant deviations from CGMP for active pharmaceutical ingredients (API). A 9/4 Warning Letter says specific violations were: * failing
Drugs
FDA has issued Mallinckrodt a complete response letter on its NDA for terlipressin and its use in treating adults with hepatorenal syndrome Type 1 (HRS-1). The letter said that, based on the available data, the agency cannot approve the NDA in its current form and it requires more information
Drugs
FDA has released a final guidance on Assessing Covid-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for Covid-19 Prevention or Treatment. The document notes that sponsors may encounter challenges in identifying methods to assess the numerous and heterogeneous Covid-
Drugs
FDA has issued a temporary guidance entitled Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency to help drug/biologic product manufacturers to “transition from operations impacted by the Covid-19 public health emergency to normal manufacturing operations.” The document provides recommendations on prioritizing products
Drugs
FDA has sent Pharmacy Plus (dba Vital Care Compounder) a Warning Letter for offering unapproved drug products — Covid Pack and Covid Positive Pack — for prophylaxis, treatment and recovery from the Covid-19 virus. The letter takes issue with statements made on the company’s Web site touting the products, such
Drugs
RLC Labs has recalled 483 lots of Nature-Throid and WP Thyroid because FDA testing of samples from six lots found them to be subpotent. “The product may have as low as 87% of the labeled amount of liothyronine or levothyroxine,” a recall notice says. Patients being treated for hypothyroidism
Biologics
The latest Kaiser Family Foundation (KFF) health tracking poll finds that 62% of Americans worry that Trump administration political pressure will lead FDA to rush to approve a coronavirus vaccine without being sure that it is safe and effective. A KFF statement says those respondents fearing pressure include 85% of
Drugs
FDA has sent Warning Letters to the operators of 17 Web sites for illegally selling unapproved and misbranded opioids. The letters went to alpharoyalpharmacy.com, beststeroidstore.net, bluepillmedications.com, buydrugsmedsonline.com, genericpharmacyusa.com, greenrxpharmacy.com, klasiekpharmacy.com, lekapharma.com, mega-pillspharmacy.com, melanopharmacy.com, roidsforce.com, rxeasymeds.com, skylimitpharmacy.com,
Biologics
As part of FDA’s ongoing effort to reaffirm its independence and integrity in the face of Covid-19 political pressures, the eight career agency executives who oversee the work of the Centers have signed a statement saying they are “following the science to protect public health” in the pandemic.
Drugs
FDA’s nervousness with gene therapies continues as it holds up a Sarepta Therapeutics clinical trial by asking for an additional potency assay to release SRP-9001 commercial process material prior to dosing in the planned Phase 3 trial. SRP-9001 is the company’s investigational gene transfer therapy for
Drugs
FDA has approved a GlaxoSmithKline supplemental NDA for Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) for treating asthma in patients aged 18 years and older. The drug product was originally approved in 2017 as the first once-daily single inhaler triple therapy for treating chronic obstructive pulmonary disease. Approval was based
Drugs
FDA commissioner Stephen Hahn and deputy commissioner for medical and scientific affairs Anand Shah say that action to bring America’s critical medical supply chain onshore and modernize infrastructure for life sciences manufacturing is long overdue. “Even prior to the pandemic, our supply chain was under pressure,” they write in
Drugs
A Pennsylvania federal court has ordered Boehringer Ingelheim (BI) to stop using some advertising claims for its COPD inhalers as requested in a suit brought by GlaxoSmithKline under the Lanham Act’s prohibition on false advertising and Pennsylvania common law. The court granted in part and denied in part Glaxo’
Drugs
FDA says its review of the Nutritional Supplements Corp. Web site determined that the company markets and takes order for three products — Vitadone, Diabrex, and Viadevita — that are considered unapproved and misbranded new drugs. An 8/25 Warning Letter reviews claims and testimonials made for each of the products. The
Drugs
Researchers from Harvard Medical School and the University of Pittsburgh say that biomedical company payments to teaching hospitals may raise concerns for institutional conflicts of interest. Writing in Health Affairs, the researchers say that 91% of teaching hospitals received industry payments totaling $832 million in 2018. “We observed substantial royalty
Drugs
An 11/11-11/15/19 FDA inspection at the PT MegaSurya Mas drug manufacturing facility in Sidoarjo, Jawa Timur, (East Java, Indonesia) found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. An 8/24 Warning Letter says specific violations were: * failing to have, for each