Devices
FDA has cleared a Misonix 510(k) for Nexus, an ultrasonic surgical platform. The company says its next-generation integrated device combines all the features of Misonix’s existing features, including BoneScalpel, SonicOne and Sonastar, into an integrated platform that will also serve to power future options. Nexus is driven
FDA Policy/General
The House Appropriations Committee has marked-up and passed the fiscal year 2020 Agriculture/FDA appropriations bill that would provide the agency with an increase in budget authority of 6% ($184 million) over 2019 levels. A House combined press release and statement said: “The FDA receives a total of $3.
Drugs
Boehringer Ingelheim says its experience as the only biosimilar sponsor to have publicly announced conducting a switching study, to support an interchangeability designation for its biosimilar Cyltezo (adalimumab-adbm), shows that the FDA pathway for biosimilars and interchangeable biologics “is working well as it is currently designed.” Commenting on an
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. ActiveHerb Technology, San Diego, CA (5/15): FDA inspected the firm 9/2018 and determined that it was selling unapproved new drugs that were misbranded. FDA documented the firm’
Drugs
FDA’s Oncology Center of Excellence has unveiled a new drug expanded access pilot program to help oncology health care professionals seeking access to unapproved therapies for patients with cancer. A new call center called Project Facilitate will be a single point of contact where FDA oncology staff will help
Drugs
Federal Register notice: FDA has withdrawn the approval of five ANDAs for products containing pemoline. The application holders requested their withdrawal and have waived their opportunity for a hearing. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has permitted the redemption of a priority review voucher associated with the recent approval of a Novartis NDA for Mayzent (siponimod) tablets, indicated for treating adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. To view
Drugs
FDA has issued a safety alert on the dietary supplement ingredient due to its potential to cause a miscarriage or harm fetal development. According to data reviewed by the agency, including a recent report by the National Institute of Health’s National Toxicology Program, consumption of vinpocetine is associated with
FDA Policy/General
FDA chief of staff Lauren Silvis has announced her departure from the agency later this month. She became chief of staff to former commissioner Scott Gottlieb 4/2017 after serving two years as CDRH deputy Center director for policy. Prior to joining FDA in 2015, she was a partner at
Drugs
FDA needs to be more transparent and announce when companies submit NDAs to the agency, according to Center for Science in the Public Interest and former associate commissioner Peter Lurie. Reacting to new FDA research on NDA notifications published in JAMA-Internal Medicine, Lurie says it makes “no sense for
Drugs
Generic drug maker Heritage Pharmaceuticals has been charged for conspiring with its competitors to fix prices, rig bids, and allocate customers, according to the Justice Department. According to the government, from about 4/2014 to 12/2015, “Heritage participated in a criminal antitrust conspiracy with other companies and individuals engaged
Devices
FDA has approved a TransMedics Group PMA for expanded clinical indications of the Organ Care System Lung to be used for the preservation and ex-vivo assessment of both standard criteria donor lungs as well as the larger pool of donor lungs initially deemed unacceptable for procurement and transplantation based
Drugs
FDA has approved a Merck NDA for a new indication for Zerbaxa (ceftolozane and tazobactam) for treating hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients 18 years and older. The drug was initially approved in 2014 to treat complicated intra-abdominal infections and for complicated
FDA Policy/General
Info Collection Extension on Supplement Notifications Federal Register notice: FDA submits to OMB an information collection extension entitled “Food Labeling; Notification Procedures for Statements on Dietary Supplements — 21 CFR 101.93.” 05/31/2019 Comments Sought on Opioid Unit-of-Use Packaging Federal Register notice: FDA seeks public comments on
FDA Policy/General
Johnson & Johnson Consumer has successfully completed the acquisition of Vogue International LLC, a privately-held company focused on the marketing, development and distribution of salon-influenced and nature inspired hair care and other personal care products, for $3.3 billion in cash. Icagen, Inc. says it has acquired Sanofi’
FDA Policy/General
DEVICES Entrotech Life has received FDA 510(k) clearance for its ChloraDerm, an edge-to-edge transparent film dressing to provide a chlorhexidine matrix for wound and catheter site protection for up to seven days. “Compared to common non-antimicrobial dressings ChloraDerm demonstrates substantially greater effectiveness against multi-drug-resistant
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Food Labeling; Notification Procedures for Statements on Dietary Supplements — 21 CFR 101.93” (OMB Control Number 0910–0331). FDA’s regulations require that, no later than 30 days after the first marketing, it be notified about specific
FDA Policy/General
Federal Register notice: FDA has announced the establishment of a docket to solicit public comments on a potential modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy to require that certain solid, oral dosage forms of immediate-release opioid analgesics commonly prescribed for treatment of acute pain be made
FDA Policy/General
Federal Register notice: FDA has announced a 7/17 public workshop entitled “Improving the Implementation of Risk-Based Monitoring Approaches of Clinical Investigations.” The workshop is intended to capture stakeholder experiences with risk-based approaches for monitoring clinical investigations and gather stakeholder input on opportunities to further the implementation of
Drugs
CDER’s Office of Prescription Drug Promotion (OPDP) has issued Vivus an untitled letter over false and misleading claims made on its Web page for weight-loss drug Qsymia (phentermine and topiramate extended-release) capsules. According to the letter, the page makes false/misleading claims and representations about the drug’
Drugs
Novis PR has recalled five lots of PexGen DMX, 16 oz, liquid cough syrup due to incorrect dosage information on its label due to a typographical error. The drug facts label incorrectly states that children six to under two years of age should receive one teaspoonful every four hours (not
Drugs
FDA and precision medicine technology company COTA, Inc. have a two-year research collaboration agreement (RCA) to establish a study protocol with an initial focus on breast cancer. Operating under FDA’s regulatory science research Information Exchange and Data Transformation (INFORMED) Program, the RCA is intended to provide the agency