FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Attention Deficit Hyperactivity Disorder (ADHD): Developing Stimulant Drugs for Treatment.” The document is intended to assist sponsors in the clinical development of stimulant drugs for treating ADHD in pediatric and adult patients. It also addresses the agency’s current
Drugs
FDA has made available a final guidance entitled “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.” The document provides an overview of the mechanisms available to submitters to request feedback from or a meeting with FDA about potential or planned medical device IDEs, PMAs, BLAs,
Devices
FDA has approved a Boston Scientific PMA for the VICI Venous Stent System for treating iliofemoral venous obstructive disease, which occurs when the flow of blood through the veins located deep in the pelvic region becomes blocked by a blood clot or compressed by anatomical anomalies. The iliofemoral veins often
Drugs
Vivimed Life Sciences has recalled 19 lots of losartan potassium tablets USP 25 mg, 50 mg, and 100 mg due to the detection of a known carcinogen — N-nitroso-N-methyl-4-aminobutyric acid (NMBA) — that is above FDA’s interim acceptable exposure limit of 9.82 ppm. The product
Devices
The New York Times editorial board is urging FDA to abolish the 510(k) medical device clearance process and fix other device regulatory loopholes amid growing reports of devices that were allowed on the market for decades without proper vetting. Just last month, FDA decided that surgical mesh products indicated
Drugs
Par Pharmaceutical has recalled one lot of mycophenolate mofetil for injection after one product vial was observed containing a glass fragment after reconstitution. “The administration of a glass particulate, if present in an intravenous drug, may result in local irritation or swelling in response to the foreign material,” a recall
FDA Policy/General
Federal Register notice: FDA has announced the renewal of its Medical Imaging Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 5/18/2021. To view the notice, click here.
FDA Policy/General
Priority Voucher Redeemed for Alexion’s Ultomiris Federal Register notice: FDA announces the approval of product that redeemed a priority review voucher — Alexion Pharmaceuticals’ Ultomiris (ravulizumab-cwvz). 05/03/2019 Update to Susceptibility Test Interpretive Criteria Page Federal Register notice: FDA has made available its annual compilation of updates to
FDA Policy/General
DEVICES AliveCor has received FDA 510(k) clearance for its Heart Monitor, a mobile ECG device, compatible with the iPhone 4 and 4S models, that enables doctors to evaluate patient heart health remotely. Ethicon Biosurgery has received FDA approval for the Evarrest Fibrin Sealant Patch, intended for use as an
FDA Policy/General
Federal Register notice: FDA has announced the approval of product that redeemed a priority review voucher — Alexion Pharmaceuticals’ Ultomiris (ravulizumab-cwvz) that was approved 12/21/2018 for treating adult patients living with paroxysmal nocturnal hemoglobinuria. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available its annual compilation of updates to the Susceptibility Test Interpretive Criteria Web page. The page was created 12/2017 to include susceptibility test interpretive criteria identified and recognized by FDA. This notice is published in accordance with procedures established by the 21st Century
FDA Policy/General
Federal Register notice: FDA has made available a list of patient preference-sensitive priorities on FDA’s Web site entitled “Patient Preference-Sensitive Areas: Using Patient Preference Information (PPI) in Medical Device Evaluation.” As part of FDA’s user fee commitments, CDRH committed to publish a list of priority areas
Drugs
FDA has released a draft guidance entitled Attention Deficit Hyperactivity Disorder (ADHD): Developing Stimulant Drugs for Treatment that provides general recommendations to companies developing such drugs. The document explains that, because ADHD is a disorder that begins in childhood, a new drug application for any drug intended to treat ADHD
Devices
FDA has cleared a Treace Medical Concepts 510(k) to expand indications of the Lapiplasty 3D Bunion Correction System to treat pediatric patients 12 years of age and older. The device is designed to correct all three dimensions of the bunion deformity and permanently secure the root cause — an unstable
Drugs
CDER director Janet Woodcock told the Food and Drug Law Institute’s annual meeting in Washington DC 5/2 that the Center has six active initiatives ongoing as part of its new drugs regulatory program modernization. These include integrated review for marketing applications, IND review management, and post-market safety
Drugs
Hi-Tech Pharmaceuticals says it has sued FDA in DC federal court claiming that the agency “bypassed standard rule-making procedures in favor of a campaign of intimidation to try to force companies to destroy their products containing 2-Aminoisopheptane, or DMHA.” The complaint states that DMHA has existed in
Drugs
Insys Therapeutics’s founder and four former executives have been convicted by a federal jury in Boston on charges they bribed health professionals to prescribe Subsys, a highly-addictive sublingual fentanyl spray intended for cancer patients experiencing breakthrough pain, and for defrauding Medicare and private insurance carriers. Insys founder John
Drugs
Janssen says that an FDA draft guidance on assessing food effects on drugs would be enhanced if the use of physiologically-based pharmacokinetic modeling were permitted and incorporated into the guidance. The company’s comment letter also includes line-by-line specific comments. Specific technical comments also were submitted by
Drugs
Researchers from Harvard Medical School and the Council on Foreign Relations say that recent trade deals containing protections for the drug industry have not always delivered benefits to Americans promised in return for the greater pharmaceutical protections. Writing in the New England Journal of Medicine, the researchers say the 1994
Drugs
FDA has posted a summary of changes made in March and April to 17 risk evaluation and mitigation strategies (REMS). The listings include approval of REMS for four testosterone NDAs, establishment of a shared system REMS for mifepristone, and an additional NDA added to the opioid analgesic shared system.
Drugs
The federal government has intervened in two whistleblower False Claims Act cases alleging that Mallinckrodt’s Questcor Pharmaceuticals unit improperly promoted an expensive multiple sclerosis drug and paid kickbacks to doctors who prescribed the drug, H.P. Acthar Gel. Reuters reports the Justice Department decided to intervene after investigating the
Devices
FDA has cleared a Lensar 510(k) for the Lensar Laser System with Streamline IV to expand the platform’s capabilities to include the creation of micro radial incisions that allow surgeons to treat additional corneal conditions post cataract surgery. The incisions are guided by the femtosecond laser platform’s