Drugs
Attorney Andrew Tauber (Winston & Strawn) says decisions by both the 1st and 2nd Circuit Courts of Appeal have broadened the definition of what constitutes a major change in a drug that must be approved by FDA before a labeling change, expanding implied preemption of cases brought in state courts.
Drugs
Building on the success of its electrocardiogram (ECG) data warehouse that supports FDA’s cardiac safety review of therapeutic product development programs, the agency has created a first-of-its-kind pediatric ECG data warehouse. The warehoused ECGs will be analyzed in pediatric product development programs to help prevent sudden
Drugs
FDA has approved Boehringer Ingelheim and Eli Lilly’s diabetes drug Jardiance (empagliflozin) 10 mg for reducing the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure with reduced ejection fraction (HfrEF). Accounting for about half of heart failure cases, HFrEF occurs when the heart
Devices
FDA has issued a letter to healthcare providers warning them to stop using and discard all ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical due to a risk of bacterial contamination with Burkholderia cepacia complex. The affected products are distributed by a number of companies under various product names,
Devices
FDA has granted a breakthrough designation to Abiomed’s Impella ECP expandable percutaneous heart pump. The device is placed percutaneously into the heart’s left ventricle to expand and support the heart’s pumping function, providing flow greater than 3.5 L/min, the company says. Impella ECP is the
Drugs
The just-released CDER FY 2020 “State of Pharmaceutical Quality” report shows a slight decrease in the number of drug manufacturing sites from 4,273 in FY 2019 to 4,221 in FY 2020. The count excludes medical gas manufacturers and newly-registered hand sanitizer manufacturers, the report says. Some
Drugs
FDA has told Virpax Pharmaceuticals that it can proceed with additional research on MMS019, a high-density molecular masking spray under development for use as an anti-viral barrier product intended to intranasally limit transmission of the viruses to others. The company says FDA indicated that it may pursue an
Biologics
Attorney Jeffrey Shapiro (Hyman, Phelps & McNamara) has three takeaways from the recent FDA final rule governing how the intended use of a distributed product is to be determined. First, he says in an FDA Law Blog post, the removal of the knowledge provision, which had seemed to problematically suggest
Devices
FDA says it is aware of potential confusion and the possibility of inappropriate medical treatment based on the color of the bracelet or wristband provided by a medical device manufacturer and given to patients to be worn as an identifier of an implanted device. An online notice says in 2008
Drugs
Tempus has submitted a PMA for its broad-panel DNA sequencing xT-Onco assay, an in vitro diagnostic device intended to assist healthcare professionals with data-driven cancer treatment decisions. The submission includes companion diagnostic claims, tumor profiling claims, and microsatellite instability status by using DNA isolated from formalin-fixed
Biologics
A February FDA inspection at Utah Cord Bank (also known as Utah Cell Bank) in Sandy, UT, has determined that the firm’s cell products StemVive and StemMaxx are unapproved. A just-posted Warning Letter says that agency investigators also documented evidence of significant GMP and good tissue practice deviations.
Devices
FDA has cleared a Globus Medical 510(k) for the Excelsius3D, an intraoperative three-in-one imaging system. The device consolidates 360-degree cone-beam computerized tomography, fluoroscopy, and high-resolution digital radiography into one unified application. It is indicated for use when a physician benefits from 2D and 3D
Drugs
FDA has released the FDA-483 issued following a 9/28/20-1/29/21 inspection at the Imprimis NJOF drug compounding outsourcing facility in Lakewood, NJ. The 12 inspection observations, some of which were repeat observations, were: * failing to thoroughly review any unexplained discrepancy, the failure of a batch
Devices
FDA wants to make the strengthening of medical device cybersecurity a top priority and will need additional legislative authorities to advance medical device safety by ensuring the agency and public have critical information about device cybersecurity. That’s the conclusion of an online MedTech Dive post based on discussions with
Devices
A 3/22-3/30 FDA inspection at Tianjin Bolang Science Technology Development Company, Tianjin Shi, China, found Quality System Regulation issues in the firm’s manufacturing of otoscopes, rigid laryngoscopes, and rigid nasopharyngoscopes. A just-released 6/17 Warning Letter says specific violations were: * failing to establish and maintain
Devices
FDA says it is working with federal partners, medical device manufacturers, and the private sector to address cybersecurity vulnerabilities in the BlackBerry QNX real-time operating system version 6.5 service pack 1 and earlier. An agency notice says the vulnerabilities may introduce risks for certain medical devices, as well
Devices
FDA has approved an Abbott PMA for the Amplatzer Amulet Left Atrial Appendage Occluder to treat people with atrial fibrillation (AFib) who are at risk of ischemic stroke. The device is intended to close the left atrial appendage (LAA), which is where blood clots can form in people suffering from
FDA Policy/General
Federal Register notice: FDA is reopening the comment period for a 7/23 notice entitled “International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; 4F– MDMB–BICA (4F–MDMB–BUTICA); Brorphine; Metonitazene; Eutylone (bk- EBDB); BMDP (3,4-Methylenedioxy-N-benzylcathinone); Kratom (mitragynine, 7-hydroxymitragynine); Phenibut.” The
Biologics
CBER says it will not object to AstraZeneca’s decision to export three lots of Covid-19 vaccine drug substance manufactured at Emergent BioSolutions’ troubled contract manufacturing facility in Baltimore. Earlier this year, Emergent was found to have significant GMP deviations that led to an agreement to shut down operations
Biologics
Pfizer and BioNTech have submitted Phase 1 data to FDA to support the evaluation of a booster dose of their Covid-19 vaccine. “The data we’ve seen to date suggest a third dose of our vaccine elicits antibody levels that significantly exceed those seen after the two-dose primary
Devices
Two Boston Scientific post-market surveillance studies (522 studies) confirm the unfavorable benefit-risk profile of now-withdrawn Boston Scientific’s transvaginal mesh for pelvic organ prolapse (POP). FDA 4/2019 ordered manufacturers of all remaining surgical mesh products indicated for the transvaginal repair of POP to immediately stop selling
Devices
FDA has granted Thermo Fisher Scientific emergency use authorizations for the TaqPath Covid-19 Fast PCR Combo Kit 2.0 and the TaqPath Covid-19 RNase P Combo Kit 2.0, assays designed with increased target redundancy to compensate for current mutations and emerging SARS-CoV-2 variants. “Both PCR-