Drugs
More than 250 Democrat members of Congress have signed an amicus brief to the 5th Circuit Court of Appeals urging it to reverse a Texas federal court ruling prohibiting FDA from allowing the sale of the abortion drug mifepristone. The members wrote the district court decision has no basis in
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says artificial intelligence (AI) presents many opportunities for industry and it supports FDA’s application of a “risk-based regulatory framework to the use of AI technologies in drug manufacturing.” In just-posted comments to the agency about a recent discussion paper on
Drugs
Some 10% of accelerated approval drugs are subsequently withdrawn and that number may continue to grow as FDA emphasizes the need to ensure a higher level of safety and efficacy for accelerated approval drugs by more closely scrutinizing the approval process. That’s the view of attorneys Dominick DiSabatino and
Drugs
An 8/23-9/2/22 FDA inspection at the Accra-Pac drug manufacturing facility, doing business as Voyant Beauty in Elkhart, IN, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 4/20 Warning Letter says specific violations were: * failing to thoroughly investigate any
Biologics
FDA has published a draft guidance, Decentralized Clinical Trials for Drugs, Biological Products, and Devices, with recommendations for sponsors, investigators, and other stakeholders on the implementation of decentralized clinical trials (DCTs) for drugs, biological products, and medical devices. The document defines a decentralized clinical trial as one in which some
Devices
FDA has granted DirectSync Surgical a breakthrough device designation for its patient-powered smart spinal fusion device. The designation is based on FDA’s review of preliminary data that determined the DirectSync Surgical interbody device may provide a more effective spinal fusion than the current standard of care, the company
Drugs
Vanda Pharmaceuticals is charging that FDA disclosed trade secrets from NDAs for the company’s Fanapt (iloperidone) and Hetlioz (tasimelteon) to companies submitting ANDAs for approval to market generic forms of the two drugs. In a 5/1 case filed with the United States Court of Federal Claims, Vanda says
FDA Policy/General
Federal Register notice: FDA is correcting a 4/12 notice about a final guidance entitled “A Risk-Based Approach to Monitoring of Clinical Investigations — Questions and Answers.” The notice contained an incorrect OMB control number. The correct control number is 0910–0014. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is establishing a public docket to collect comments on methodological challenges related to patient experience data associated with benefit-risk assessments and product labeling. The request for comments is mandated in the recently reauthorized drug user fee program as part of the agency’s commitment to
FDA Policy/General
Federal Register notice: CDER’s Office of Prescription Drug Promotion (OPDP) is proposing to conduct new research entitled “Perceptions of Prescription Drug Products with Medication Tracking Capabilities.” OPDP says it has noticed an increase in the number of claims and presentations in prescription drug promotion that focus on a product’
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Certification of Identity for Freedom of Information Act and Privacy Act Requests.” The collection supports Form FDA 3975 — Certification of Identity, which is used by to identify an individual requesting a particular record under the Freedom of
Drugs
FDA posted 5/2 five additional deemed final orders, completing the process of posting 33 deemed final orders for 32 different monograph therapeutic categories and one for non-monograph conditions as part of over-the-counter drug monograph reform under the CARES Act. All of the deemed final orders are
Drugs
FDA has placed a partial clinical hold on Sun Pharma’s Deuruxolitinib (CTP-543), a JAK inhibitor being evaluated for treating alopecia areata, after reporting a serious adverse event (pulmonary embolism) that occurred in a patient taking a 12 mg BID dose in a long-term open label extension study.
FDA Policy/General
Federal Register notice: FDA is announcing a 6/14 public workshop entitled “FDA Science Forum 2023.” This year’s workshop is intended to inform the public about the kinds of research underway at the agency, and demonstrate how cutting-edge science forms the basis of its regulatory decision-making to
Devices
FDA has approved a Medtronic PMA for its Micra AV2 and Micra VR2 next-generation miniaturized, leadless pacemakers. The devices are designed to provide longer battery life and easier programming than prior Micra pacemakers, the company says. The Micra AV2 device also includes advanced algorithms that automatically program atrioventricular (AV)
FDA Policy/General
Federal Register notice: FDA is seeking comments on the draft document entitled “Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Elements and Terminologies,” which is intended for use with PQ/CMC data submitted electronically. The agency says it seeks input on the accuracy, suitability, and appropriateness of revised and
FDA Policy/General
Federal Register notice: FDA has announced the availability of a final guidance for industry entitled “S12 Nonclinical Biodistribution Considerations for Gene Therapy Products.” The document provides harmonized recommendations for the conduct and overall design of such studies. To view the notice, click here.
Drugs
Astellas Pharma and Pfizer say they will discuss with FDA the filing of a supplemental NDA for Xtandi (enzalutamide) plus leuprolide for use in men with non-metastatic hormone-sensitive prostate cancer. The potential submission would be based on just-announced data showing the combination therapy significantly reduced the risk
Drugs
FDA has accepted for priority review a Bristol Myers Squibb supplemental BLA for Reblozyl (luspatercept-aamt) that seeks an expanded indication to include treating anemia without previous use of erythropoiesis-stimulating agents (ESA-naïve) in adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS) who may require blood
Drugs
Representatives Sara Jacobs (D-CA) and Cory Mills (R-FL) have introduced bipartisan legislation to minimize and prevent future drug shortages. The lawmakers says their Drug Shortage Prevention Act was drafted in response to shortages of children’s Tylenol and Motrin over the past few months. It would require manufacturers
Drugs
FDA has issued Ascendis Pharma a complete response letter on its NDA for TransCon PTH (palopegteriparatide), indicated for treating adults with hypoparathyroidism. The agency letter cited manufacturing control strategy concerns related to the variability of the delivered dose in the drug/device combination product, according to the company. FDA did
Devices
FDA has issued Princeton BioMeditech an emergency use authorization for its Covid-19 Antigen Rapid Test for Home Use, an over-the-counter Covid-19 antigen diagnostic test that produces results in 15 minutes. “The test can be used for serial testing for people who have symptoms within the first