Drugs
FDA has published a draft guidance, Antibacterial Therapies for Patients with an Unmet Medical Need for the Treatment of Serious Bacterial Diseases—Questions and Answers (Revision 1), to assist sponsors in developing new antibacterial drugs. Specifically, the document explains the agency’s current thinking about possible development programs and clinical
Drugs
Vanda Pharmaceuticals is asking the DC federal court to set aside FDA’s denial of fast track status for the company’s tradipitant to treat gastroparesis and order the agency to reconsider Vanda’s application based on the statutory framework. The suit says the fast track designation is intended to
Drugs
FDA has placed a clinical hold on an INmune Bio Phase 2 trial for XPro 1595, a next-generation inhibitor of tumor necrosis factor (TNF) that is designed to neutralize soluble TNF without affecting trans-membrane TNF or TNF receptors. The company says the hold is related to an agency
Drugs
FDA has released the FDA-483 issued following a 5/2-5/10 inspection at Aurobindo Pharma, a drug manufacturer in Mahaboob Nagar, Telangana, India. The inspection observations were: * investigations of an unexplained discrepancy and a failure of a batch or any of its components to meet any of its
Drugs
FDA principal deputy commissioner Janet Woodcock and two staff from the agency’s Office of Women’s Health say there have been improvements in the representation of women in clinical trials submitted in FDA marketing applications. “We are encouraged by the potential for new strategies to further their representation,” the
Drugs
Three FDAers and an AstraZeneca researcher say physiologically-based biopharmaceutics modeling (PBBM) is an evolving field and interest in using it is increasing. Writing online in Pharmaceutical Research, the four say that FDA has emphasized the use of patient-centric quality standards and clinically relevant drug product specifications over the
Drugs
Researchers from several universities say drug manufacturers pursue new formulations of blockbuster drugs and those granted accelerated approval, but do so less frequently once generic competition begins. Writing in JAMA Health Forum, the researchers say that in their cross-sectional study of 206 branded drugs approved by FDA in tablet
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The European Medicines Agency’s human medicines committee has recommended suspending the marketing authorizations of several generic medicines tested by India’s Synchron Research Services, a contract research organization. An EMA notice says the recommendation comes after irregularities were found in how Synchron carried out bioequivalence studies, which raised serious
Drugs
FDA has denied a 7/8/21 petition submitted by Lassman Law+Policy on behalf of an unnamed client asking that the agency take four restrictive actions related to a United Therapeutics Corporation NDA for Tvvaso DPI (treprostinil) inhalation powder. The agency denial letter says the drug’s risks are
Drugs
CDER says its researchers are helping to develop more realistic laboratory models of the mouth-throat region that allow the generic drug industry to efficiently test their metered-dose inhaler (MDI) products and speed access to generic products. A Center Impact Story says experiments in a recent study measured the
Drugs
Teva is recalling one lot of anagrelide capsules, USP 0.5 mg, due to dissolution test failure. The company notified customers on 5/11 that the lot was recalled. An FDA notice says Teva distributed 4,224 bottles nationwide from 7/30/2020 through 9/02/2020 to its wholesale,
Drugs
More Product-specific Bioequivalence Guides 05/20/2022 Federal Register notice: FDA has made available additional draft and revised draft product-specific guidances. The documents provide product-specific recommendations on, among other things, bioequivalence study design to support ANDA submissions. To view the notice, click here. Science Board to Discuss
Drugs
DEVICES BioArchitects has gained FDA clearance to introduce its titanium patient specific cranial/craniofacial implants. The company says the plates are printed on Arcam AB‘s additive manufacturing 3D printers that use electron beam melting technology designed using CAD based on patient CT or MRI scans. FDA has cleared a
Drugs
Congresswoman Jan Schakowsky (D-IL) and congressman Bruce Westerman (R-AR) have reintroduced the bipartisan Price Relief, Innovation, and Competition for Essential Drugs (PRICED) Act to make prescription drugs more affordable and accessible for Americans across the nation. The measure aims to “addresses one of Big Pharma’s most effective
Drugs
FDA has placed a partial clinical hold on a Foghorn Therapeutics Phase 1 dose escalation study of FHD-286 in relapsed or refractory acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS). The hold follows a report on the recent death of a subject with potential differentiation syndrome, which is associated
Drugs
Federal Register notice: FDA is withdrawing approval of 21 ANDAs from multiple applicants after they notified the agency that the products were no longer marketed. To view the notice, click here.
Drugs
FDA has approved Regeneron’s Dupixent (dupilumab) for treating eosinophilic esophagitis (EoE) in adults and pediatric patients 12 years and older weighing at least 40 kilograms. EoE is a chronic inflammatory disorder in which eosinophils, a type of white blood cell, are found in the esophagus, according to an FDA
Drugs
House Energy and Commerce Committee Republican leaders have asked FDA commissioner Robert Califf to answer questions about a growing trend for clinical trials to rely solely on enrollment of patients from a single country, particularly China, and the history of fabricated data in clinical trials conducted in China. The Republican
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FDA has published a draft guidance, Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Premarket Notification, indicating the agency’s intent to exercise enforcement discretion for a limited period and in limited circumstances to encourage dietary supplement firms to correct past failures to submit
Drugs
CDER Office of Pharmaceutical Quality (OPQ) director Michael Kopcha says the agency is moving toward drafting and implementing regulations on pharmaceutical advanced manufacturing technology. Speaking during a PharmTech Drug Solutions podcast, Kopcha said manufacturing advances have been slow to occur in the pharmaceutical industry due to company concerns about regulations.
Drugs
FDA has published a draft guidance, Risk Management Plans to Mitigate the Potential for Drug Shortages, to help stakeholders develop, maintain, and implement risk management plans (RMPs) to proactively assist in preventing human drug product and biological product shortages. The document says RMPs can provide stakeholders with a framework to
Drugs
Medical journals should beef up their transparency efforts regarding disclosures about the “relationships of authors to companies with financial interests related to topics they write about,” according to Public Citizen’s Health Research Group founder and senior advisor Sidney Wolfe and Weill Cornell Medical College professor Martin F. Shapiro. The