Devices
FDA has posted a draft guidance entitled “Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program.” The document describes FDA policy on the agency’s participation in the Voluntary Improvement Program (VIP), which is run by the Medical Device Innovation Consortium and uses third-party appraisals
Drugs
FDA has extended by three months its review of a Myovant Sciences and Pfizer supplemental NDA for Myfembree (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) for managing moderate to severe pain associated with endometriosis. FDA told the companies that it requires additional time to review
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Feasibility and Early Feasibility Clinical Studies for Certain Medical Devices Intended to Therapeutically Improve Glycemic Control in Patients with Type 2 Diabetes Mellitus.” The document’s scope applies to devices such as neurostimulators, and those that mimic or result
Devices
A new Pew Charitable Trusts survey finds that most participants expressed support for reform that would increase FDA’s oversight of lab-developed tests (LDTs). The Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2021 is a “solid foundation to achieve this goal,” Pew said, adding that Congress should
Drugs
Robert Califf admits that his return to the FDA top post gives him an opportunity to address “unfinished business from the first time around,” when he served as commissioner during the final year of the Obama administration (2016 to 2017). In an JAMA online interview with deputy editor Greg Curfman,
Devices
Lasik injury advocate and Vision Advocacy president Paula Cofer has stepped up pressure on FDA commissioner Robert Califf, sending him a second “illegal advertisement” for the EVO Visian implantable collamer lens (ICL) and asking that the agency take action against the promotions that are “masquerading as a news article.” The
Devices
FDA is warning about the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) with the following Fresenius Medical Care hemodialysis machines (models 2008T, 2008K2, and 2008K). The 2008K2 and 2008K models are no longer manufactured but may still be in
Drugs
A CDER self-audit of continuous manufacturing regulatory submissions and outcomes identified no substantial barriers associated with common regulatory interactions related to the implementation of continuous manufacturing as compared to batch manufacturing. A study report in the International Journal of Pharmaceutics, also says there are potential regulatory and clear economic
Drugs
FDA has approved Daiichi Sankyo’s Enhertu (fam-tastuzumab deruxtecan-nxki) for adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting or in the neoadjuvant setting and have developed disease recurrence during or within six
Drugs
An FDA-sponsored study found that for patients undergoing properly monitored levothyroxine treatment over time, those who switched among generic drug products maintained the same level of thyroid function as those who consistently used a single levothyroxine product. As reported in Spotlight on CDER Science, the study was not designed
Drugs
FDA has released the FDA-483 with 15 observations issued following a 4/29-6/15/21 inspection at Qualgen, an Edmond, OK, outsourcing facility. The observations were: * failing to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers,
Drugs
A 4/8 BioCryst voluntary decision to pause enrollment in clinical trials of its oral Factor D inhibitor, BCX9930, has transitioned to an FDA partial clinical hold. In a 5/5 quarterly financial report, the company says the hold was related to observed elevations in serum creatinine seen in some
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Antimicrobial Animal Drug Distribution Reports and Recordkeeping — 21 CFR 514.87“ (OMB Control Number 0910-0659). The collection supports FDA regulations that require sponsors of approved or conditionally approved applications for new animal drugs containing an antimicrobial
Drugs
Psychiatrist Brian Barnett says the effective and relatively inexpensive schizophrenia drug clozapine “is rarely prescribed in the U.S. largely because of its onerous REMS (Risk Evaluation and Mitigation Strategy) requirements.” Writing in a Stat online opinion piece, Barnett says the REMS is intended to address agranulocytosis, a rare but
Devices
FDA has published a guidance, Feasibility and Early Feasibility Clinical Studies for Certain Medical Devices Intended to Therapeutically Improve Glycemic Control in Patients with Type 2 Diabetes Mellitus, with agency recommendations for studies on the medical devices. The document says manufacturers frequently request FDA feedback about feasibility and early feasibility
FDA Policy/General
A House Energy and Commerce Committee legislative package (see story) to reauthorize FDA user fee agreements and enhance other agency program areas appears to address an agency predicament caused by a 2021 appeals court decision that has disrupted FDA’s orphan drug program. Last week, FDA officials testifying at a
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies.” The document describes agency recommendations on deciding whether and when to conduct such studies, study designs, and reporting results. To view the notice, click here.
Devices
FDA has cleared a VideaHealth 510(k) for its Videa Caries Assist, an artificial intelligence-powered dental caries (cavity) detection algorithm. The device is designed to aid in the analysis of radiographs instantly from a dentist’s examination chair, according to the company. The clearance is based on trial data
Biologics
FDA 5/5 limited the emergency use authorization (EUA) of Janssen’s (Johnson & Johnson) Covid-19 vaccine to individuals 18 years of age and older for whom other Covid-19 vaccines are not accessible or clinically inappropriate, citing its risk of thrombosis with thrombocytopenia syndrome. It is also indicated
Devices
Attorney Bradley Thompson (Epstein Becker Green) says it is possible to use FDA data on medical device inspection observations and Warning Letters to attempt to determine which observations might lead to Warning Letters. In a detailed online post that goes through the methodology he used as a regulatory data scientist,
FDA Policy/General
Federal Register notice: FDA has announced its renewal of the Anesthetic and Analgesic Drug Products Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 5/1/2024. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Use of Circulating Tumor DNA for Early-Stage Solid Tumor Drug Development.” The document is intended to help sponsors planning to use circulating cell-free plasma derived tumor deoxyribonucleic acid as a biomarker in cancer clinical trials conducted under