FDA Policy/General
Federal Register Final rule: FDA is amending the animal drug regulations to reflect application-related actions for NADAs and ANADAs during May and June including Elanco Animal Health’s Inteprity, Aratana Therapeutics’ Entyce, Elanco U.S.’s Onsior tablets for dogs, and Med-Pharmex’ Mometavet,. The agency is also informing
Biologics
FDA has approved a Seqirus BLA for Afluria Quadrivalent (influenza vaccine) for use in those 18 years of age and older for active immunization against influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. The product comes in single-dose, preservative-free pre-
FDA Policy/General
DEVICES FDA Corrects Notice on FY ’16 CDRH Guidances Federal Register Notice: FDA is correcting a notice entitled “Medical Device User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal Year 2016 Proposed Guidance Development,” that appeared in the 12/29/15 Federal Register. It announced
FDA Policy/General
Federal Register Notice: FDA is seeking public comment on the collection of information required to implement user account management functions in FDA’s Import Trade Auxiliary Communication System (ITACS). Secure user accounts will allow import trade users to receive Notices of FDA Action and requests for specific information via email
FDA Policy/General
Federal Register Notice: FDA is making available a guidance for industry entitled Microbiology Data for Systemic Antibacterial Drugs — Development, Analysis, and Presentation. Its purpose is to assist sponsors in the development, analysis, and presentation of microbiology data during antibacterial drug development. This guidance finalizes the draft guidance of the same
Drugs
Illinois attorney general Lisa Madigan has filed a lawsuit against Insys Therapeutics for “deceptively marketing” and selling Subsys, described as a highly addictive opioid drug indicated for treating breakthrough cancer pain. Madigan says the company illegally marketed the pain killer to physicians for treating non-cancer patients for off-label
Drugs
FDA has granted Mallinckrodt a fast track designation for Synacthen Depot (tetracosactide) and its use in treating Duchenne muscular dystrophy. The synthetic 24 amino acid melanocortin receptor agonist is approved and marketed outside of the U.S. for certain autoimmune and inflammatory conditions. Currently, the first patients have been dosed
Drugs
FDA has granted Biotie Therapies an orphan drug designation for its BTT1023 drug candidate for treating primary sclerosing cholangitis (PSC), which is a chronic and progressive fibrotic liver disease for which there are currently no FDA-approved treatments. The company says BTT1023 is a fully human monoclonal antibody targeting Vascular
Drugs
FDA has granted Lupin Ltd. tentative approval for its ANDA for paroxetine extended-release tablets, 12.5 mg, 25mg and 37.5 mg, generic copies of GlaxoSmithKline’s anti-depressant Paxil CR. “The tentative approval letter delays final approval of the generic drug product until all patent or exclusivity issues
Devices
CDRH plans to improve medical device review consistency and predictability during the next user fee cycle (FY 2018-2022) through “enhanced supervisory oversight and routine quality audits,” according to just-posted minutes of an 8/15 user fee negotiation meeting that agreed to a draft commitment letter (see earlier story)
Drugs
FDA has released a guidance on “Microbiology Data for Systemic Antibacterial Drugs — Development, Analysis, and Presentation” that is intended to assist sponsors in the development, analysis, and presentation of microbiology data during antibacterial drug development. The guidance finalizes a draft document that was issued 9/2009. The final guidance was
Drugs
FDA has issued a complete response letter for Amgen’s NDA for Parsabiv (etelcalcetide) for treating secondary hyperparathyroidism in adult patients with chronic kidney disease on hemodialysis. The company says it is reviewing the letter and anticipates a post-action meeting with the agency later this year to discuss it.
Drugs
Lilly says it will appeal an Indiana federal court ruling that its formulation patent for the testosterone treatment Axiron was invalidated and therefore would not be infringed by commercialization of generic forms of the drug. The court also determined that an underarm applicator patent was valid but also would not
Devices
In a safety communication to healthcare professionals, FDA says that when using programmable syringe pumps to infuse therapies at low rates (less than 5 mL per hour and especially less than 0.5 mL per hour), an inconsistent rate of delivery can result in serious clinical consequences, including delay of
Drugs
CDRH says it is creating a new Pediatric Extrapolation for Devices (PED) team to evaluate and review device submissions that include data extrapolation in seeking pediatric indications. The PED team is part of the Center’s implementation efforts involving a final guidance on “Leveraging Existing Critical Data for Extrapolation to
Devices
FujiFilm Medical Systems has submitted the final PMA module for its digital breast tomosynthesis, an optional software upgrade for the Aspire Cristalle digital mammography system. The upgrade includes the company’s hexagonal close pattern detector pixel design, which is designed to “enhance detail for improved low dose performance compared to
Drugs
The Biotechnology Innovation Organization (BIO) says that it and its members recognize the importance of understanding and considering the needs and preferences of the patients they serve. “To ensure BIO and its members understand and can thoughtfully address what is most important to patients, their caregivers, and their families, we
Devices
Columbia University College of Physicians and Surgeons researchers say that among women who underwent minimally invasive hysterectomy from 2013 to the first quarter of 2015, power morcellation was used in 13.5% in the first quarter of 2013, peaked at 13.7% by the fourth quarter of that year, and
Drugs
FDA says it will begin accepting 9/3 Risk Evaluation and Mitigation Strategies (REMS) documents in “structured product labeling (SPL)” formats as a means to standardize the documents and eventually integrate them into electronic healthcare records. Currently, there are 75 approved REMS, with 42 of those having the most restrictive
Devices
A citizen petition filed on behalf of five individuals who were damaged by electroshock therapy (also known as electroconvulsive therapy or ECT) asks FDA to either ban use of the devices or keep them in Class 3 and set a date for premarket approval for all such devices. The petition
FDA Policy/General
Federal Register Notice: FDA is making available a guidance for industry entitled Abbreviated New Drug Application Submissions — Refuse to Receive for Lack of Justification of Impurity Limits. It is intended to assist applicants preparing to submit to FDA ANDAs and prior approval supplements for which the applicant is seeking approval
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance for industry entitled Current Good Manufacturing Practice Requirements for Food for Animals. The document helps domestic and foreign facilities that are required to register as food facilities under the FD&C Act determine whether and how they need to