Drugs
FDA is holding a 3/23 public workshop titled “Identification of Concepts and Terminology for Multi-Component Biomarkers.” The workshop will “address the need to identify standardized high-level conceptual terminology, its potential hierarchy, and include specific language to describe the range of multi-component biomarkers and their application to
Drugs
FDA has published a draft guidance, Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed, with recommendations for applicants seeking licensure under section 351(k) of the Public Health Service Act of a proposed biosimilar or interchangeable biosimilar for
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it appreciates FDA efforts to advance patient-focused drug development through a guidance and public workshop. The association says it agrees with FDA on the importance of sponsors engaging with the agency early to discuss clinical outcome assessment development strategy. It recommends
Drugs
Researchers from Harvard Medical School and Northwestern University say their evaluation of hundreds of millions of antibiotic prescriptions dispensed to Medicaid recipients “revealed an alarmingly high proportion of prescriptions that were not infection-related or visit based.” Writing in Health Affairs, the researchers say that identifying the risks associated with
Drugs
FDA has released the FDA-483 issued following a 1/20-1/28 inspection at the Dr. Reddy’s API manufacturing facility in Srikakulam District, Andhra Pradesh, India. The five observations on the form were: * failing to adequately perform process validation for manufactured products at the facility; * investigations are inadequate
Drugs
Former FDA commissioner Scott Gottlieb has joined Illumina’s board of directors. Illumina says it is focused on DNA sequencing and array-based technologies, serving customers in the research, clinical, and applied markets. Since leaving FDA 4/2019, Gottlieb has been appointed to the FasterCures advisory board, Pfizer’ board of
Drugs
Gilead Sciences is working with Chinese health authorities to begin a randomized, controlled study to determine whether the company’s remdesivir can safely and effectively be used to treat the coronavirus (2019-nCoV) outbreak. In a 2/5 Gilead statement, the company says it is also “expediting appropriate laboratory testing
Drugs
Federal Register notice: FDA has made available a draft guidance entitled “Mucopolysaccharidosis Type III (Sanfilippo Syndrome): Developing Drugs for Treatment.” The document is intended to enhance clinical trial data quality and support development of such treatments. It covers eligibility criteria, trial design considerations, and efficacy endpoints for use in clinical
Drugs
A Medscape commentary says that some of the public speakers addressing an FDA advisory committee have had their expenses and time paid for by the drug companies whose products are being considered. The commentary (free membership required) references a study in BMJ Evidence-Based Medicine that makes clear that “individuals
Drugs
FDA has released the FDA-483 with five observations from a 1/13-1/17 inspection at the Lupin API manufacturing facility in Andhra, Pradesh, India. The specific observations are: * critical process parameters should be controlled and monitored during process validation studies; * there is a failure to thoroughly review any
Drugs
FDA says consumers should avoid using dietary supplements containing cesium chloride or any other cesium salt due to significant safety risks such as heart toxicity and potential death. The agency says in an online notice that it also is conveying the warning to healthcare professionals. The notice says that multiple
Drugs
A 5/14-5/22/19 FDA inspection at Marco Pharma, Roseburg, OR, found serious violations of current good manufacturing practice (CGMP) regulations for dietary supplements. A 1/10 Warning Letter says significant violations were: * failing to establish the required specifications for any point, step, or stage in the manufacturing
Drugs
Former Washington Legal Foundation (WLF) chief counsel Richard Samp asks how FDA justifies its continuing efforts to bar drug manufacturers from disseminating information on off-label uses of their products when the agency itself is facilitating “crowdsourcing” of off-label information through its CURE ID program launched 12/2019. “FDA
Drugs
FDA has granted EyeYon Medical a breakthrough device designation for its EndoArt Artificial Endothelial Layer Implant. The polymer film implant is intended to be attached to the posterior corneal surface to treat chronic corneal edema secondary to endothelial dysfunction. A nonfunctioning endothelium results in corneal homeostasis loss due to excess
Drugs
Romark Laboratories, which manufactures and distributes Alinia (nitazoxanide) tablets for oral use and for oral suspension, indicated for treating some cases of diarrhea, is asking FDA not to approve any ANDA for a generic form of its products unless the applicant satisfies bioequivalence provisions proposed by Romark. The company’s
Drugs
FDA has announced a 3/5 workshop on “Advancing Animal Models for Antibacterial Drug Development.” The workshop is set to discuss ongoing research efforts to advance animal model development for serious bacterial infections. The agency will also discuss challenges encountered in animal model development and ideas for future research. Discussions
Drugs
FDA says that its 2/4-2/8/19 inspection of Evig LLC, doing business as Balance of Nature, St. George, UT, found serious violations of the Federal Food, Drug, and Cosmetic Act in the firm’s manufacturing and marketing of Whole Fruit Foods, Whole Food Veggies, and Whole Food
Drugs
FDA has issued a draft guidance, Mucopolysaccharidosis Type III (Sanfilippo Syndrome): Developing Drugs for Treatment, to make recommendations to sponsors about eligibility criteria, trial design considerations, and efficacy endpoints to enhance clinical trial data quality and foster greater efficiency in developmental programs for drugs to treat Sanfilippo syndrome. The document
Drugs
In a 1/31 interview with Politico, new FDA commissioner Stephen Hahn stressed product safety as he talked about drug importation, generic drug approvals, cannabidiol products, and the coronavirus. Hahn was confirmed one day before the Trump administration announced its plan to allow states to import cheaper drugs from Canada.
Drugs
FDA has approved an expanded label for Merck’s insomnia drug Belsomra (suvorexant) C-IV to include findings on its use for treating insomnia in patients with mild-to-moderate Alzheimer’s disease. Belsomra is indicated for the treatment of insomnia characterized by difficulties with sleep onset or sleep maintenance.
Drugs
ML Strategies senior director Aaron Josephson says changes are likely to be made in the medical product user fee programs that are starting the reauthorization process this year. In an online post, Josephson highlights some changes made to the programs when they were last reauthorized through the 2017 FDA Reauthorization
Drugs
FDA has posted laboratory results showing N-Nitroso dimethylamine (NDMA) levels in some metformin products approved in the U.S. The testing, which is part of FDA’s ongoing investigation into NDMA impurities in certain drug products, showed that metforminֺ products range from “not detectable to low levels.” To date,