Biologics
FDA has approved a Ferring Pharmaceuticals BLA supplement for intravesical gene therapy Adstiladrin (nadofaragene firadenovec-vncg) and the company’s plan to scale-up its drug substance manufacturing process at FinVector Oy located in Kuopio, Finland. The company says supplies from the scale-up process manufactured at FinVector’s facility
FDA Policy/General
FDA needs new policies geared toward integrating artificial intelligence (AI) into drug and medical product development, according to former FDA commissioner Scott Gottlieb and his former chief of staff Lauren Silvis. Writing in the 6/8 online JAMA Forum, they say that integrating AI “technologies into the current regulatory frameworks
Devices
FDA is alerting health care providers and facilities on the use of oxygenators in extracorporeal circulation following a recent recall by Getinge/Maquet of its Quadrox oxygenators and certain Getinge/Maquet venous hardshell cardiotomy reservoirs due to potentially compromised packaging sterility that may result in the risk of infection and
Drugs
FDA’s Peripheral and Central Nervous Systems Drugs Advisory Committee 6/9 voted 6 to 0 that data from the Phase 3 CLARITY AD trial verified the clinical benefit of Eisai/Biogen’s Leqembi (lecanemab) in the early treatment of Alzheimer’s disease. Eisai received accelerated approval for Leqembi 1/
Devices
FDA has cleared a SurGenTec 510(k) for its TiLink-L Sacroiliac Joint Fusion System, a device that can be implanted from a lateral or posterior/oblique approach. The company says the device’s design allows for superior compression across the joint, and it features SurGenTec’s proprietary Nanotex surface
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Clinical Drug Interaction Studies With Combined Oral Contraceptives.” The document is intended to help drug sponsors evaluate whether they need drug-drug interaction studies with combined oral contraceptives (COCs). It also covers the design of such studies, how to
FDA Policy/General
Federal Register notice: FDA is announcing the renewal of its Dermatologic and Ophthalmic Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 10/7/2024. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is issuing an order to permanently debar Analay Rico from providing services in any capacity related to an approved or pending drug product application. FDA bases the order on Rico’s 8/2022 guilty plea related to her role as a clinical research coordinator at Tellus
Drugs
Senators Mike Braun (R-IN), Kirsten Gillibrand (D-NY), Lisa Murkowski (R-AK), Kevin Cramer (R-ND) and Roger Wicker (R-MS) have introduced the Promising Pathway Act, a bill to help Americans with amyotrophic lateral sclerosis (ALS/Lou Gehrig’s Disease) and other life-threatening diseases receive early access
Drugs
Novartis says a current FDA guidance on patient preference information (PPI) pertains only to medical device development. “A common guidance on PPI that applies to devices, drugs, and drug-device combinations would help medicine developers in consistently applying the same principles and methods throughout medical product development,” the company says
Drugs
FDA has published a guidance, Assessing User Fees Under the Generic Drug User Fee Amendments of 2022, with an explanation of the new fee structure and types of fees for which entities are responsible under changes made in the GDUFA 3 reauthorization in 2022. The document describes the types of
Drugs
FDA has approved a Novaliq NDA for Vevye (cyclosporine ophthalmic solution) 0.1% for treating the signs and symptoms of dry eye disease. Approval was based on data from 1,369 patients with dry eye disease, which demonstrated that the product was safe, well tolerated, and has a consistent, and
Drugs
Attorneys Dominic DiSabatino and Audrey Crowell (SheppardMullin) say the most notable change in two FDA draft guidances clarifying its approach to requirements and incentives for pediatric drug development is the agency’s intent to increase the clinical trial requirements for obtaining pediatric exclusivity. Writing in an online post, DiSabatino and
Drugs
In its 2022 report to Congress on drug shortages, FDA says its response to the Covid-19 pandemic highlighted two needs that require ongoing work to be fully addressed: * gaining better insight into the supply chain since manufacturers are not required to notify FDA of increases in demand that they
Drugs
FDA has published a guidance, Clinical Drug Interaction Studies with Combined Oral Contraceptives, to help sponsors of INDs and NDAs evaluate the drug-drug interaction (DDI) effects of their investigational drugs on combined oral contraceptives (COCs), design interaction studies, and determine how to communicate DDI study results and risk mitigation
Drugs
FDA has accepted for review a Merck supplemental BLA for Keytruda in combination with standard-of-care chemotherapy (gemcitabine and cisplatin) for treating patients with locally advanced unresectable or metastatic biliary tract cancer. The submission is based on data from the KEYNOTE-966 trial that showed Keytruda plus chemotherapy had
Devices
FDA has approved an Avita Medical PMA supplement for use of its Recell System to treat full-thickness skin defects. “The expanded indication represents a broad label of full-thickness skin defects, such as wound injuries after traumatic avulsion (e.g., degloving), surgical excision (e.g., necrotizing soft tissue infection)
FDA Policy/General
Federal Register notice: FDA has determined that Bristol Myers Squibb’s Buspar (buspirone HCl) was not withdrawn due to safety or effectiveness reasons. The determination will allow FDA to approve ANDAs that reference the product if all other legal and regulatory requirements are met. Buspar was originally approved 12/2000
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Importation of Prescription Drugs — 21 CFR Part 251.” The collection supports implementation of Section 804 of the Federal Food, Drug, and Cosmetic Act, which is intended to reduce the cost of covered products to American consumers without
FDA Policy/General
Federal Register notice: FDA is announcing the renewal of the Antimicrobial Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 10/7/2024. To view the notice, click here.
Drugs
FDA has selected CDER Office of Generic Drugs (OGD) safety and clinical evaluation acting director Iilun Murphy to serve as the next OGD director, replacing Sally Choe, who left the agency eight months ago to pursue opportunities outside the agency. CDER Office of Lifecycle Drug Products director Susan Rosencrance, who
Drugs
FDA has approved commercial production at a Bristol Myers Squibb cell therapy manufacturing facility in Devens, MA. The company says the site is its third commercial CAR T (chimeric antigen receptor cell therapy) manufacturing facility in the U.S.