Drugs
FDA has updated summary table forms (XXINSERT LINKXX) for ANDA submissions containing clinical endpoint studies. The previous version has been updated, and now includes two separate documents — one for submissions containing comparative clinical endpoint bioequivalence studies, and the other for submissions containing irritation/sensitization/adhesion studies (for transdermal and topical
Devices
FDA has granted BioDirection a breakthrough device designation for its Tbit System for the prediction of positive computerized tomography scans following a traumatic brain injury. The device is designed to measure the body’s response to trauma and provide a rapid point-of-care test result in less than two
Drugs
FDA has issued 12 Warning Letters and five online advisory letters to foreign and domestic companies that are “illegally” selling more than 58 products, which include dietary supplements, that are unapproved or misbranded drugs because they are claiming to treat Alzheimer’s disease and other serious health conditions. The products,
FDA Policy/General
FDA Seeks Industry Reps to Serve on Advisory Committees Federal Register notice: FDA requests nominations for nonvoting industry representatives to serve on its public advisory committees for CDER. 02/08/2019 Info Collection Extension for Generic Drug Fee Coversheet Federal Register notice: FDA submits to OMB an information collection extension
FDA Policy/General
DEVICES FDA has cleared a Tyber Medical 510(k) for TyFix, an all-in-one extremity joint fixation system. The device is designed to eliminate the use of the ancillary instrumentation for a wide range of bone fixation procedures, including hammertoe correction, according to the company. In addition, the all-
FDA Policy/General
Federal Register notice: FDA is requesting that any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on its public advisory committees for CDER notify FDA in writing. The agency is also requesting direct individual nominations for nonvoting industry representatives to serve on CDER’s
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for its “Generic Drug User Fee Coversheet” (OMB Control Number 0910-0727). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced the start of a pilot program under the Drug Supply Chain Security Act, which is intended to assist FDA and members of the pharmaceutical distribution supply chain in developing electronic, interoperable system that will identify and trace certain prescription drugs as they are distributed
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Public Warning and Notification of Recalls.” The document is intended to increase and expedite the appropriate and accurate use of public warnings and public notification and to increase public health protection by better informing the public about violative products
Devices
FDA has approved an Orthofix Medical PMA for the M6-C artificial cervical disc for patients suffering from cervical disc degeneration. The device was developed by Spinal Kinetics, a company acquired by Orthofix 4/2018. The next-generation artificial disc is designed to restore physiologic motion to the spine, and
Drugs
FDA has approved a Perrigo ANDA for a generic copy of GlaxoSmithKline’s Zovirax Cream, 5% (acyclovir cream), indicated as an antiviral treatment for cold sores. Annual sales for acyclovir cream is about $92 million, according to Perrigo.
Devices
FDA has released a guidance entitled “Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements.” The agency says the devices identified in the guidance are sufficiently well understood and do not require premarket notification (510(k)) to assure their safety and effectiveness. Until the publication of a final
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Opioid Use Disorder: Developing Depot Buprenorphine Products for Treatment.” The document outlines the agency’s perspective on drug product development and trial design issues relevant to the study of depot buprenorphine products (i.e., modified-release products for injection
FDA Policy/General
Federal Register notice: FDA has announced the start of a pilot program under the Drug Supply Chain Security Act, which is intended to assist FDA and members of the pharmaceutical distribution supply chain in developing electronic, interoperable system that will identify and trace certain prescription drugs as they are distributed
Drugs
Johnson & Johnson pharmaceutical group Janssen says it is taking the lead to begin including list price information in drug direct-to-consumer (DTC) TV ads. Later this quarter, the company says pricing disclosures will begin with its oral anti-coagulant Xarelto, and the advertising will include both the list
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Principles of Premarket Pathways for Combination Products” that discusses how to determine which type of premarket submission is appropriate. FDA has published the draft as mandated by the 21st Century Cures Act. To view the notice, click here.
Drugs
FDA has issued a final guidance outlining circumstances when a company should issue a public warning about a voluntary recall, describing the general timeframe for companies to issue such a warning, discussing what information should be included in a public warning, and describing situations where FDA may take action to
Drugs
A new report on citizen petitions submitted to FDA to delay or prevent a drug/biosimilar approval finds that only one product was delayed approval due to such a filing, but the agency is concerned about the number of resources re-directed to meet statutory response timelines. In the report
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it supports FDA’s efforts to update its 2005 final guidance on good review management principles and practices (GRMP) for NDAs and BLAs. “Due to the proposed updates and streamlining in the draft guidance,” the association says, “PhRMA strongly urges the agency
Drugs
CDER has issued a Manual of Policies and Procedures (MAPP) on the responsibilities and procedures for developing a single, shared system risk evaluation and mitigation strategy (REMS) or a separate REMS with elements to assure safe use. The MAPP does not include information on other agency actions, such as complete
Drugs
FDA has approved a Grifols PMA for the Procleix Babesia assay, a qualitative test for detecting ribosomal RNA from four Babesia species (B. microti, B. duncani, B. divergens, B. venatorum) in individual samples or up to 16 pooled lysed specimens from human donors, including donors of whole blood and blood
Drugs
Vanda Pharmaceuticals has filed a complaint against FDA in DC federal court seeking to remove a partial clinical hold the agency “illegally imposed prohibiting Vanda from studying a promising new drug in humans for more than 12 weeks without conducting unnecessary and unethical animal studies.” The affected drug is tradipitant,