Drugs
Responding to an FDA draft guidance on developing drugs and biologics for adjuvant treatment of bladder cancer, Novartis says it applauds the agency’s efforts to seek input from stakeholders on actionable policy suggestions that could be implemented in the near-term by CDER Office of New Drugs staff to
Drugs
In a suit filed in a Maryland federal court, Genus Lifesciences says that Lannett Company made untrue statements to FDA in an NDA for its Numbrino, a cocaine-based anesthetic, and the agency has not performed its legal duty to withdraw approval of the NDA. The suit acknowledges that Genus
FDA Policy/General
Speculation is growing as to who will be selected as FDA commissioner under the incoming Biden Administration, and two familiar names are circulating the rumor mill. Former commissioner David Kessler (11/8/1990 to 2/28/1997) and former principal deputy commissioner Joshua Sharfstein (2009–2011) are reportedly top contenders.
FDA Policy/General
Federal Register notice: FDA has announced the renewal of its Pharmacy Compounding Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 4/25/2022. To view the notice, click here.
FDA Policy/General
Research!America and 75 other organizations have contacted Senate majority leader Mitch McConnell (R-KY) and House Speaker Nancy Pelosi (D-CA) to urge that Congress address two national imperatives: * approval of an FY 21 appropriations package that includes increased funding for Covid-relevant and strategically pivotal agencies such as
Devices
FDA says it is prioritizing the review of emergency use authorization (EUA) requests for Covid-19 tests based on factors such as the public health need for the product and product availability. An update to the Frequently Asked Questions related to Covid-19 test development and review says the agency
Drugs
FDA says that MPM Medical, Mesquite, TX, is recalling one lot of Regenecare HA Hydrogel due to contamination with the bacteria Burkholderia cepecia. An agency notice says Regenecare HA Hydrogel is an over-the-counter product containing 2% lidocaine that is used topically for temporary relief of pain and itching
Biologics
Former CBER Division of Manufacturing and Product Quality reviewer and investigator John Godshalk has joined NDA Partners as an expert consultant. An NDA announcement says Godshalk is an expert in chemistry, manufacturing, and controls, quality, and facility issues for cell and gene therapies, and has experience with biologics, vaccines, drugs,
Devices
FDA has cleared a Viveve Medical 510(k) to expand its manufacturing capacity for its consumable treatment tips used with the company’s Cryogen-cooled Monopolar Radiofrequency (CMRF) technology. CMRF is used with the Viveve System, which is indicated for use in general surgical procedures for electrocoagulation and hemostasis. Viveve
Biologics
Janssen Pharmaceutical has submitted a BLA for amivantamab for treating patients with metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy. The fully-human EGFR and mesenchymal epithelial transition factor (MET) bispecific antibody
Drugs
FDA is alerting health care professionals about the risk of inadvertent intrathecal administration with tranexamic acid injection, which may result in serious life-threatening injuries, including seizures, cardiac arrhythmias, paraplegia, permanent neurological injury, and death. “In most of the cases reported to FDA, tranexamic acid injection was erroneously administered instead
Biologics
TG Therapeutics has begun a rolling BLA submission for ublituximab, a glycoengineered anti-CD20 monoclonal antibody, in combination with umbralisib, the company’s dual inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with chronic lymphocytic leukemia. The submission is based on data from the UNITY-CLL
Devices
FDA says it has updated the SARS-CoV-2 reference panel comparative data on the agency Web site to reflect the latest information. An FDA notice says the reference panel is an independent performance validation step for diagnostic tests of SARS-CoV-2 infection that are being used for clinical
Drugs
FDA has approved a Vanda Pharmaceuticals NDA for Hetlioz (tasimelteon) capsule and liquid formulations for treating adults and children with nighttime sleep disturbances associated with Smith-Magenis Syndrome (SMS). The rare neurodevelopmental disorder, which involves an “inverted” circadian rhythm, makes it extremely difficult for patients with SMS to sleep during
FDA Policy/General
Federal Register notice: FDA has announced a 12/17 Vaccines and Related Biological Products Advisory Committee meeting. Panel members are scheduled to discuss an emergency use authorization request by Moderna for its Covid-19 vaccine. The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform.
FDA Policy/General
Federal Register notice: FDA is publishing a list of information collections that have been approved by OMB. They are: * Focus Groups as Used by the Food and Drug Administration * Food Canning Establishment Registration, Process Filing and Recordkeeping for Acidified and Thermally Processed Low-Acid Foods * Color Additive Certification Requests and
Drugs
FDA has approved an additional indication for Blueprint Medicine’s Gavreto (pralsetinib) to treat patients with advanced or metastatic RET-mutant and RET-fusion-positive thyroid cancer. The company says the accelerated approval expands the labeled instructions to include adult and pediatric patients age 12 or older with advanced or
Drugs
A 3/19/18-3/23/18 FDA inspection at West Coast Nuclear Pharmacy, Tampa, FL, found “serious deficiencies in your practices for producing sterile drug products, which put patients at risk.” A just-released 10/6 Warning Letter says that under current law, radiopharmaceuticals that are compounded by entities
Devices
FDA has published a Web page with answers to frequently asked questions relating to the development and use of transport media during the Covid-19 public health emergency. “These questions and answers provide additional clarity on existing policies and do not introduce any new policies or modify existing policies,” the
Devices
Fujirebio Diagnostics has submitted a 510(k) for the Lumipulse G β-Amyloid Ratio (1-42/1-40) in vitro diagnostic test for use in assessing Alzheimer’s disease. The test uses Fujirebio’s automated Lumipulse G1200 instrument system to analyze results. According to Fujirebio, the device combines the concentrations
Devices
FDA has posted the transcript from a 10/27 CDRH public meeting on reauthorizing the Medical Device User Fee Act (MDUFA) program. During the meeting, FDA commissioner Stephen Hahn acknowledged the resource strain from the current Covid-19 emergency on the Center’s ability to continue to meet user fee
Drugs
FDA says it is accepting research proposals focused on assessing the impact of extended-infusion of beta-lactam antibacterial drugs on the development of beta-lactam resistance and patient outcomes. Specifically, a notice (includes a link to the research announcement) says, the agency will prioritize research proposals focused on evaluating