Drugs
FDA has granted MicuRx Pharmaceuticals fast track status and a qualified infectious disease product designation for contezolid (MRX-I) and its prodrug contezolid acefosamil (MRX-4) for treating acute bacterial skin and skin structure infections. The company describes contezolid and contezolid acefosamil as next-generation oxazolidinone agents with reduced hematologic
Drugs
CDER director Janet Woodcock says FDA is considering whether there is more it can do under the FDA Safety and Innovation Act to better address drug shortages. Speaking in a Center podcast, Woodcock says they are researching whether they have the ability to require applicants of certain drugs to identify
Drugs
FDA has released the FDA-483 issued following a 4/3-4/12 inspection at ADMA Biologics, Boca Raton, FL. The document’s eight observations were: * failing to prevent unauthorized access of changes to data and to provide adequate controls to prevent omissions of data; * failing to control issuance and
Drugs
FDA says its review of all postmarketing reports of deaths and serious adverse events reported with use of Acadia Pharmaceuticals’ Parkinson’s drug Nuplazid (pimavanserin) did not identify any new or unexpected safety findings or findings that are inconsistent with the established safety profile described in the drug label. “After
Drugs
FDA has released the FDA-483 issued after a 7/23-7/28 and 7/30-8/3 agency inspection at Zhejiang Huahai Pharmaceutical Co., Linhai, Zhejiang Province, China. The 11 observations on the form were: * failing to have an adequate change control system to evaluate all changes that may
Drugs
An FDA pre-approval product inspection at the Strides Pharma Sciences formulations facility in Bangalore, India, was completed 8/25, resulting in issuance of an FDA-483 with three observations. The company says it believes the agency’s observations are not material in nature and says it has already responded
Drugs
FDA has granted OBI Pharma an orphan drug designation for OBI-3424 for treating acute lymphoblastic leukemia. OBI-3424 is a first-in-class DNA alkylating cancer therapeutic agent targeting aldo-keto reductase 1C3 overexpressing cancers, the company says. In July, the therapy was granted orphan status for treating hepatocellular
Biologics
FDA has issued a draft guidance describing its current thinking on civil money penalties relating to requirements to submit registration and/or results information to ClinicalTrials.gov and/or certain certifications to FDA. The draft addresses these questions: * how CBER, CDER, and CDRH intend to identify whether responsible parties have
Drugs
The Clinical Trials Transformation Initiative has released a one-page summary of a 6/2018 expert meeting it convened to discuss best practices and needed resources for advancing use of real-world evidence in randomized clinical trials. The meeting included investigators, patients, regulators, technology experts, sponsor representatives, and other groups,
Drugs
Janssen Pharmaceutical has submitted an NDA seeking approval of erdafitinib for treating patients with locally advanced or metastatic urothelial cancer and certain fibroblast growth factor receptor (FGFR) genetic alterations whose tumors have progressed after prior chemotherapy. Erdafitinib is an investigational oral pan-FGFR inhibitor that received breakthrough therapy designation from
Drugs
California has filed a lawsut against AbbVie alleging that it gave illegal kickbacks to health care providers to prescribe Humira (adalimumab), indicated for multiple inflammatory diseases. The whistleblower-based suit, which was filed under the Insurance Frauds Prevention Act, alleges that private insurers have paid out $1.2 billion in
Drugs
FDA has published three guidances relating to product identifier requirements under the Drug Supply Chain Security Act. A draft guidance, Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers, is intended to address anticipated questions about product identifiers required for packages and homogenous cases of certain drug
Drugs
CDER has issued a Manual of Policies and Procedures to provide guiding principles and approaches for establishing drug substance and drug product impurity acceptance criteria for non-mutagenic impurities in NDAs, ANDAs, and BLAs, based on the consideration of clinical relevance. Currently, the MAPP says, establishment of a drug substance
Drugs
Arca Biopharma has submitted a special protocol assessment request for its planned Phase 3 clinical development program of Gencaro (bucindolol hydrochloride) as a genetically-targeted treatment for heart failure patients at risk for atrial fibrillation (AF). The submission details a single adequate and well-controlled Phase 3 clinical trial (PRECISION-
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says an FDA draft guidance on collecting comprehensive and representative patient input issued under the PDUFA 6 goals letter will help “advance science-based approaches to collecting, analyzing, interpreting, and incorporating robust and meaningful patient data into the drug development and review process.
Drugs
FDA has approved a final Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) that now applies to immediate-release opioid analgesics intended for use in an outpatient setting. The new REMS also applies to the extended-release and long-acting opioid analgesics that have been subject to a REMS since
Drugs
A 3/20-3/23 FDA inspection at the Jabones Y Productos Especializados drug manufacturing facility in Jalisco, Mexico, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 9/5 Warning Letter says specific violations were: * failing to have, for each batch of drug product,
Drugs
International Contrast Ultrasound Society (ICUS) has petitioned FDA urging it to remove boxed warnings from ultrasound contrast agents (UCAs) based on current “highly favorable safety data and clinical experience.” The group’s petition cited studies showing that the contrast agents are safe, improve patient care, reduce overall health care costs,
Drugs
A 9/18-10/10/17 FDA inspection at Pharmaceutical Laboratories and Consultants, Addison, IL, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals at the contract testing laboratory. A just-released 8/29 Warning Letter says similar deficiencies were cited in 2007, 2009, 2012, and
Drugs
FDA has denied a 2/25/09 petition submitted by a physician asking that the agency “recall all vaccines that contain ingredients that have not been shown to be safe.” The agency denial letter says that some of the contentions raised in the petition were substantially similar to those in
Drugs
FDA has cleared a WAT Medical 510(k) for its HeadaTerm for treating migraine headaches. The device uses “precision transcranial electrical stimulation technology to target the pain receptors in the brain via neuromodulation,” the company says. “By sending a particular frequency of electrical stimulation, pain-relieving hormones like endorphins are
Drugs
Severing FDA’s historical independence from drug economics, commissioner Scott Gottlieb has suggested that new innovative payment/reimbursement mechanisms should be developed to allow drug companies to capture a greater upfront share of the social value of antibiotic drug development. In a 9/14 post, Gottlieb indicated that the agency