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
FDA Policy/General
FDA 5/31 kicked off a long-awaited public hearing on “Scientific Data and Information About Products Containing Cannabis or Cannabis-Derived Compounds” by reiterating concerns about drug-like claims touted by product marketers. “Our biggest concern is the marketing of products that put the health and safety of consumers
Biologics
CBER’s Office of Compliance and Biologics Quality has sent an untitled letter to R3 Stem Cell because its Web site promotes its “regenerative stem cell therapies” without an approved BLA. “We note that your products are intended to treat a variety of serious or life-threatening diseases or conditions,
Devices
FDA has approved a Stryker PMA for the Neuroform Atlas Stent System, an aneurysm adjunctive stent for treating wide-neck, intracranial aneurysms in conjunction with embolic detachable coils. The device was previously approved under a humanitarian device exemption restricting use to specific hospitals with institutional review board approval. Approval was
Drugs
CDER Office of Surveillance and Epidemiology director Gerald Dal Pan says that although the number of reports to the FDA Adverse Event Reporting System (FAERS) reached a record of more than two million in 2018, that does not suggest that FDA-approved drugs have become riskier. In a CDER Conversation:
FDA Policy/General
Federal Register notice: FDA has determined that AbbVie’s Lupron (leuprolide acetate) injection, 1 mg/0.2 mL, was not withdrawn from sale for reasons of safety or effectiveness. The determination allows FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal
Drugs
FDA has announced a 7/17 public workshop entitled “Improving the Implementation of Risk-Based Monitoring (RBM) Approaches of Clinical Investigations.” The workshop is intended to capture stakeholder experiences with risk-based approaches to monitoring of clinical investigations and gather stakeholder input on opportunities to further implement risk-based approaches
Drugs
FDA has approved an Astellas Pharma supplemental NDA to update the U.S. product labeling for Xospata (gilteritinib) to include final analysis data from the ADMIRAL trial. The data demonstrated improvement in overall survival in patients treated with gilteritinib monotherapy versus salvage chemotherapy in adult patients with relapsed or refractory
Drugs
Five FDAers working in various CDER positions involving cancer drugs and treatment say the agency is working to help resolve a problem that occurs when patients and their families don’t understand information they are given about a cancer diagnosis and treatment options. Writing in an open-source article in
Devices
FDA has cleared a Medivis 510(k) for its SurgicalAR, an augmented reality technology platform for surgical applications and its clinical use in the operating room. The company says the device “integrates the latest advancements in augmented reality, artificial intelligence, and computer vision to advance surgical visualization, thereby decreasing surgical