Devices
The Covid-19 emergency has had the unintended consequence of cementing the use of real-world evidence (RWE)and real-world data (RWD) in product submissions at FDA. Writing in a Med Device Online 11/4 article, Hogan Lovells attorneys Kelliann Payne, Blake Wilson, and Megana Sankaran predict RWE will
Drugs
FDA has approved a Sedor Pharmaceuticals NDA for Sesquient (fosphenytoin sodium for injection) for treating status epilepticus in adult and pediatric patients. The company says that the ready-to-dilute and room temperature drug is the only FDA-approved fosphenytoin that allows point-of-care storage, as well as fast
Drugs
FDA has extended its review of a Lipocine NDA resubmission for Tlando, an oral testosterone product candidate for hormone replacement therapy in adult males for conditions associated with hypogonadism. The agency had set a user fee review action date of 8/28, and now FDA says it will make its
Drugs
FDA says Nostrum Laboratories has recalled four lots of extended-release metformin because it may contain N-nitrosodimethylamine (NDMA) above the acceptable intake limit. An agency notice says the recall covers two lots of 500 mg tablets and two lots of 750 mg tablets. The agency maintains a recalled metformin
FDA Policy/General
Federal Register notice: FDA has announced the establishment of a docket to solicit public comment on a proposal to publish a summary of FDA’s review of Risk Evaluation and Mitigation Strategy (REMS) assessments. The purpose of the docket is to increase agency transparency and promote exchange of information regarding
Drugs
FDA has accepted a BioMarin NDA for vosoritide, an investigational, once-daily injection analog of C-type natriuretic peptide for children with achondroplasia, described as the most common form of disproportionate short stature in humans. The company says this is the first marketing application accepted by FDA for a treatment
Drugs
Bluebird Bio says it has reached a general agreement with FDA that the clinical data package required to support a BLA submission for LentiGlobin for sickle cell disease will be based on data from a portion of patients in a study group that have already been treated. The company says
Drugs
FDA has accepted for review AstraZeneca’s anifrolumab, an investigational drug for treating moderate to severe systemic lupus erythematosus (SLE). The agency is expected to make a review decision in the third quarter next year. The submission was based on data from the two TULIP Phase 3 trials and the
FDA Policy/General
Federal Register notice: FDA has announced a 12/11 public workshop entitled “Evaluating the Effect of the Opioid Analgesics Risk Evaluation and Mitigation Strategy Education Program on Prescribing Behaviors and Patient Outcomes — Exploring the Path Forward for Assessment.” Its purpose is to obtain scientific input on methods to evaluate the
Drugs
FDA has approved Chiesi USA’s Bronchitrol (mannitol) inhalation powder, described as the first and only inhaled dry powder indicated as add-on maintenance therapy to improve pulmonary function in cystic fibrosis patients age 18 and older. A company statement says that in three clinical trials totaling 761 patients age
Drugs
FDA and drug industry representatives are exploring manufacturing and inspection “interests” as part of their Prescription Drug User Fee Act (PDUFA) reauthorization discussions. A recent meeting saw industry explaining its main themes of interest in manufacturing and inspections, such as “enhancing pre-market and post-market communication, increasing understanding of
Drugs
FDA will hold an online virtual public workshop entitled “Evaluating the Effect of the Opioid Analgesic Risk Evaluation and Mitigation Strategy Education Program on Prescribing Behaviors and Patient Outcomes — Exploring the Path Forward for Assessment.” A Federal Register notice says the workshop will be held on 12/11. Three major
Drugs
Eli Lilly says it has a high degree of confidence in the quality of the active pharmaceutical ingredient (API) made in Branchburg, NJ following two recent FDA inspections that cited GMP deficiencies (see earlier story). A just-posted Form FDA-483 issued after an August reinspection at the company’s
Drugs
An 11/18-12/6/19 FDA inspection at Surgery Pharmacy Services, Chattanooga, TN, found serious deficiencies in the firm’s practices for producing compounded sterile drug products, putting patients at risk. A just-released 10/9 Warning Letter describes issues with drug products that were expected to be sterile
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Medical Devices; Device Tracking — 21 CFR Part 821” (OMB Control Number 0910-0442). The federal Food, Drug, and Cosmetic Act gives FDA authority to require a manufacturer to adopt a method for tracking a Class 2 or
Drugs
An FDA briefing document prepared for the 11/6 meeting of the Peripheral and Central Nervous System Drugs Advisory Committee speaks positively about Biogen’s Alzheimer’s drug aducanumab that the committee will discuss. An agency medical reviewer says one of the clinical studies submitted by Biogen “provides substantial evidence
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
Devices
Researchers from Yale University and several other academic centers say that in their study, a large proportion of first-time implantations of cardioverter-defibrillator ICD) and cardiac resynchronization therapy-defibrillators (CRT-D) were performed by doctors who received payments from medical device manufacturers. “Patients were more likely to receive ICD
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
Biologics
The Biotechnology Innovation Organization (BIO) says it appreciates efforts by CDRH and CBER to develop a guidance on patient-reported outcome (PRO) instruments for use in medical product evaluation. BIO’s comment letter says that while PROs are an important tool for collecting and reporting patient experiences, the trade group
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