Drugs
The CDER Office of Pharmaceutical Quality (OPQ) has published a Manual of Policies and Procedures (MAPP) describing the policies and procedures for OPQ product quality assessors to ensure consistent assessment of excess volumes in injectable drug products packaged into vials. The MAPP addresses both liquid and solid drug products that
FDA Policy/General
A Stat opinion column written by Columbia University Vagelos College of Physicians and Surgeons psychiatry department chair Jeffrey Lieberman criticizes Democrats who have expressed concerns about the nomination of Robert Califf as FDA commissioner. The column specifically cites Sens. Bernie Sanders (I-VT), Elizabeth Warren (D-MA), and Joe Manchin
Drugs
CDER senior policy advisor Brooke Higgins says FDA has seen inspection trends in aseptic technique and behaviors; facility, room, and process design; and the use of media fills. An online report in Healthcare Packaging covers Higgins’ presentation at the 9/2021 Parenteral Drug Association/FDA joint regulatory conference. “We know
Drugs
FDA has accepted for review a Samsung Bioepis/Organon sBLA for their citrate-free, high-concentration formulation of SB5 (adalimumab-bwwd), a biosimilar candidate referencing AbbVie’s Humira (adalimumab). A Samsung statement says FDA previously approved SB5 as Hadlima, a low-concentration formulation of Humira, in 7/2019. Samsung Bioepis
Devices
FDA has cleared a Helios Cardio 510(k) for CardiaMend Pericardial and Epicardial Reconstruction Matrix, an acellular collagen matrix derived from fetal bovine dermis that is indicated for both pericardial repair and reconstruction, and epicardial support and repair. The device is supplied in a variety of sizes and two thickness
FDA Policy/General
Federal Register notice: FDA has issued an order debarring William Kulakevich for five years from importing or offering for import any drug into the U.S. The debarment is based on Kulakevich’s previous felony conviction related to asetizolam sales to consumers through his Web site (www.etizy.com). The
Drugs
A 9/13-9/14 FDA inspection at a clinical test site maintained by a physician in Kyiv, Ukraine, conducted as part of the agency’s Bioresearch Monitoring Program, found “objectionable conditions.” A 12/21/21 Warning Letter says it appears that the site did not adhere to statutory and
Biologics
An FDA review of a Web site and YouTube channel maintained by Aspen Institute for Regenerative Medicine and Anti-Aging determined that the firm markets cellular products derived from umbilical cord blood or adipose tissue to treat diseases or conditions such as congestive heart failure, ischemia, chronic obstructive pulmonary disease
Devices
Attorney Bradley Thompson (Epstein, Becker & Green) says the county in which a medical device manufacturing facility is located “has a big impact on the likelihood of inspection” by FDA. Writing in the National Law Review, Thompson says his analysis did not show a relationship between FDA district offices or
FDA Policy/General
The Senate Health, Education, Labor & Pensions Committee has pushed back a 1/5-scheduled confirmation vote on FDA commissioner nominee Robert Califf until 1/15. No explanation for the delay has been given, but some are speculating on weather effects after the Washington, DC region was slammed by a
Devices
Attorneys Jeffrey Gibbs and Gail Javitt say FDA policies and decisions have contributed to the current shortage of Covid diagnostic tests and the agency needs to look at its policies and actions and make changes before the next pandemic comes. Writing in their firm’s FDA Law Blog, Gibbs and
Drugs
FDA is asking the Isotretinoin Products Manufacturers Group (IPMG) to consider a potential temporary solution to help resolve issues patients, prescribers, and pharmacies are experiencing with the implementation of the modified iPLEDGE risk evaluation and mitigation strategy (REMS). An agency document says issues include an inability to log in to
Drugs
FDA says its review of a Web site maintained by Amcyte Pharma, Kirkland, WA, determined that the company offers Nasitrol for sale in the U.S. to mitigate, prevent, treat, diagnose, or cure Covid-19 in humans. A 1/3 Warning Letter says Nasitrol is an unapproved and misbranded drug
Drugs
FDA has granted AbbVie a breakthrough therapy designation for telisotuzumab vedotin (Teliso-V) and its use in treating patients with advanced/metastatic epidermal growth factor receptor wild type, nonsquamous non-small cell lung cancer (NSCLC) with high levels of c-Met overexpression whose disease has progressed on or after platinum-
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Obtaining Information To Understand Challenges and Opportunities Encountered by Compounding Outsourcing Facilities” (OMB Control Number 0910-0883). To view the notice, click here.
Devices
The Cybersecurity and Infrastructure Security Agency published a 12/21/21 vulnerability medical advisory on the Fresenius Kabi Agilia Connect Infusion System. An FDA notice cautions that successful exploitation of the system’s vulnerabilities could allow an attacker to gain access to sensitive information, modify settings, or perform arbitrary actions
Biologics
FDA has amended the Pfizer/BioNTech emergency use authorization for their Covid-19 vaccine to: * expand the use of a single booster dose to include those ages 12-15; * shorten the time between the completion of primary vaccination with the product and a booster dose to at least five months;
Devices
In an update on Center activities and resources, CDRH director Jeffrey Shuren and Office of Product Evaluation and Quality director William Maisel say they will work in 2022 toward a gradual transition to normal review timelines from the changes that were made to accommodate staff needs for Covid-19 activities.
Drugs
FDA has classified as Class 1 a recall by Medtronic’s Covidien unit of its Puritan Bennett 980 Ventilator Series System due to a manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. Customers have been told
Drugs
The New Jersey federal court has ordered Natural Solutions Foundation and its two principals to stop distributing unapproved and misbranded “nano silver” products promoted as a treatment for Covid-19. A Department of Justice statement says the company operated various Web sites to promote its products that purportedly contained silver
Drugs
FDA has approved Coherus BioSciences’ Yusimry (adalimumab-aqvh), a biosimilar form of AbbVie’s Humira (adalimumab). The American Journal of Managed Care reports it is indicated for plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, Crohn's disease, and ulcerative colitis. Yusimry is the seventh Humira
Biologics
Novavax says it will apply for an FDA emergency use authorization for its Covid-19 vaccine this month, extending slightly the 12/31/21 deadline it previously announced. Reuters reports the company has delayed its U.S. submission multiple times due to development and manufacturing issues. The company released data