Devices
FDA has issued a final guidance on Regulatory Considerations for Microneedling Products. The document is intended to assist industry in understanding when a microneedling product is a device for regulatory purposes. It also provides information on the regulatory pathway to market for microneedling devices for esthetic use. According to the
FDA Policy/General
Context Therapeutics, a biopharma company dedicated to developing new medicines for patients with hormone responsive cancers, announced that it has acquired from Arno Therapeutics the worldwide rights to Apristor (onapristone XR). Onapristone has been studied in two Phase 2 metastatic breast cancer clinical trials. In these trials, meaningful clinical benefit
Drugs
Draft Guide on Population Pharmacokinetics Federal Register notice: FDA makes available a draft guidance entitled “Population Pharmacokinetics (PK)” to assists sponsors in applying PK during drug development. 09/25/2020 Draft Guide on Hormonal Drug Product Development Federal Register notice: FDA releases a draft guidance on Hormonal Contraceptive Drug Product
Devices
FDA is implementing a certification program for medical devices not exported from the U.S., which is mandated under the Coronavirus Aid, Relief, and Economic Security Act. If certain requirements are met, a Certificate for Device Not Exported from the U.S. (CDNE) may be issued upon request, an agency
Drugs
FDA has released a final guidance on “Insanitary Conditions at Compounding Facilities.” The document describes examples of insanitary conditions that FDA has observed during inspections. It specifically addresses drugs (including biological products) produced by pharmacies, federal facilities, and outsourcing facilities that compound or repackage drugs, or that mix, dilute, or
Drugs
Senhwa Biosciences says its clinical partner, Center for Advanced Research and Education in Gainesville, GA, has received a study-may-proceed letter from FDA to begin a Phase 2 trial evaluating silmitasertib, a novel orally available casein kinase 2 inhibitor for treating moderate Covid-19 patients. “The Covid-19 clinical
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