Drugs
FDA has released the FDA-483 issued following an 8/25-9/3 inspection at STAQ Pharma, a Denver, CO, outsourcing facility. Specific inspection observations were: * failing to include the conclusions and follow-up in written records of investigations into unexplained discrepancies; * failing to include adequate validation of the aseptic
Drugs
FDA and the generic drug industry are each offering proposals to advance earlier ANDA approvals, according to minutes of a 10/1 Generic Drug User Fee Amendments negotiation meeting. Industry representatives focused on proposals around a pre-submission of facility correspondence program, transparency and communication enhancements, and greater use of
Drugs
Bristol Myers Squibb has announced positive results from POETYK PSO-1, a pivotal Phase 3 trial evaluating deucravacitinib (BMS-986165), a novel, oral, selective tyrosine kinase 2 inhibitor for treating patients with moderate to severe plaque psoriasis. POETYK PSO-1 evaluated 6 mg of deucravacitinib once daily and it met
Drugs
A 2/24-3/17 FDA inspection at Cosmax USA, Ridgefield Park, NJ, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 10/15 Warning Letter says specific violations were: * failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of
Drugs
FDA says its review of a Web site maintained by Immusist LLC, Gig Harbor, WA, determined that the company is selling two unapproved new drugs — Immusist Original and Immusist Natural — intended for use in the cure, mitigation, treatment, or prevention of disease. A 10/16 Warning Letter lists Web site
Drugs
FDA has approved updated prescribing information for Emmaus Life Sciences’ Endari (L-glutamine oral powder) to better inform healthcare professionals and sickle cell disease patients. The updated label includes a statement that the clinical benefit of Endari was observed irrespective of hydroxyurea usage and a new step-by-step instructions
Drugs
FDA has granted Salix Pharmaceuticals an orphan drug designation for rifaximin and its use in treating sickle cell disease. Early data suggest that rifaximin may reduce vaso-occlusive crisis in patients with sickle cell disease, the company says. Salix says it is finalizing Phase 2 trial protocols to further evaluate
Drugs
In April, the White House reportedly ordered the National Strategic Stockpile to distribute 23 million hydroxychloroquine tablets from its inventory to a dozen states for treating Covid-19 patients. The drug shipments were sent to several commercial distributors with orders to send them directly to hospitals and retail pharmacies in
Drugs
Significant quality and laboratory control issues are cited in a just-posted Form FDA-483 issued to Eli Lilly after an August reinspection at its Imclone manufacturing facility in Branchburg, NJ. The GMP problems could pose a hurdle for a promising Covid-19 drug that will be made there. Last
Drugs
An FDA/industry Prescription Drug User Fee Act reauthorization subgroup met recently to discuss the agency’s plans on risk evaluation and mitigation strategies (REMS) assessment modernization under the next user fee program that starts in late 2022, according to a summary of the meeting. FDA says its REMS proposals
Drugs
FDA commissioner Stephen Hahn says that the agency, the U.S. Customs and Border Protection (CBP)and the U.S. Immigration and Customs Enforcement have signed a memorandum of understanding (MOU) to stop harmful products that pose a threat to public health and attempt to enter the U.S. through
Drugs
Janssen Pharmaceutical has submitted a supplemental NDA for paliperidone palmitate 6-month (PP6M) for treating adults diagnosed with schizophrenia. If approved, PP6M will be the first and only long-acting injectable schizophrenia medication with a twice-yearly dosing regimen, Janssen says. FDA approved a Janssen NDA in 2015 for Invega
Drugs
FDA has released a revised guidance on Providing Regulatory Submissions in Electronic Format — Standardized Study Data. The document and technical specifications documents it incorporates by reference describe the requirements for an electronic submission of standardized clinical and nonclinical study data. The guidance revises the types of submissions that are exempted
Drugs
FDA is seeking to advance efforts associated with its Cell and Gene Therapy Program (CGTP) and Digital Health Program, according to FDA summaries of meetings with industry on negotiating the reauthorization of the Prescription Drug User Fee Act. The agency has proposed to “enhance resources for the existing CGTP in
Drugs
Tricida says it was surprised by comments made by representatives of the CDER Division of Cardiology and Nephrology at a 10/20 end-of-review conference on its investigational drug veverimer. The drug is a non-absorbed, orally-administered polymer designed to treat metabolic acidosis in patients with chronic kidney
Biologics
FDA has entered into a Cooperative Research and Development Agreement with Emulate, Inc., to enable multiple studies across FDA Centers in priority research areas, including programs to evaluate Covid-19 vaccines and understand human response against SARS-CoV-2. Emulate says that under the agreement the agency will use a
Drugs
A 2018 symposium panel with researchers from FDA, Johns Hopkins, and two private companies say the design and analysis of clinical studies play critical roles in evaluating and characterizing heterogeneous treatment effects. A special issue paper in the journal Pharmaceutical Statistics says researchers “can do more or better at understanding
Drugs
CDER researchers say that timely development of product-specific guidances, including those for complex generic drugs, along with prioritizing complex generic drug research, may facilitate ANDA submissions and promote generic drug price competition. A CDER Regulatory Science Impact Story post describes Center research into the factors that may predict the
Drugs
FDA is pitching a plan to enhance its Model-Informed Drug Development (MIDD) activities under the next iteration of its Prescription Drug User Fee Act (PDUFA) program, which is up for renewal 9/2022. During a recent FDA/Industry PDUFA subgroup negotiation meeting on regulatory decision tools, the agency discussed
Drugs
FDA has reached a five-year agreement with SomaLogic to evaluate the utility of large-scale analysis of proteins (proteomics) for identifying biomarkers that may be useful in demonstrating biosimilarity of a proposed biosimilar to a reference biologic. The company says it will collaborate with FDA to identify circulating pharmacodynamic
Drugs
FDA has published a guidance, Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products, to give sponsors recommendations on the nonclinical information to support the development and approval of orally inhaled nicotine-containing drug products, including electronic nicotine delivery systems intended for smoking cessation and related chronic indications. The document
Drugs
Four stakeholders are praising the FDA draft guidance on evaluating cancer drugs in patients with central nervous system (CNS) metastases and offering suggested changes. Bristol-Myers Squibb says the draft guidance is intended to provide clarity on study procedures and data requirements to support a label claim for benefit to