Devices
A 6/27-6/30/2023 FDA inspection at Dr. Joel Kaplan Inc. in San Diego, CA, determined there were multiple violations in the firm’s manufacturing and distribution of several male and female sexual health enhancement devices. A 1/8 Warning Letter discusses information from the devices’ product inserts
Drugs
Many doctors are not familiar with how FDA regulates new drugs and medical devices, according to the results of a survey conducted by researchers at the University of California San Francisco (UCSF). The researchers say that doctors may be under the impression that the data supporting drug and medical device
Drugs
Hemogenyx Pharmaceuticals says it has submitted a complete response to the FDA clinical hold on the company’s IND for HEMO-CAR-T. A company statement says the complete response is necessary before it can obtain agency consent to start Phase 1 trials of HEMO-CAR-T in acute myeloid
Drugs
An FDA summary of its 10/18-10/19/2023 virtual public meeting on “Mitigating Clinical Study Disruptions During Disasters and Public Health Emergencies,” calls for maintaining momentum started under the Covid-19 public health emergency to embrace modernization and continue innovations in clinical research. The meeting and publication of
Biologics
FDA has approved a Vertex Pharmaceuticals BLA for Casgevy (exagamglogene autotemcel [exa-cel]), a CRISPR/Cas9 gene-edited cell therapy for treating transfusion-dependent beta thalassemia (TDT) in patients 12 years and older. This is the second approval granted for Casgevy; the first approval was granted 12/9/2023 for
FDA Policy/General
Federal Register notice: FDA is announcing the approval of a product that redeemed a material threat medical countermeasure priority review voucher — Novartis’ Fabhalta (iptacopan), indicated as monotherapy for treating adults with paroxysmal nocturnal hemoglobinuria. The agency determined that the drug application, which was approved 12/5/2023, met the voucher
Devices
FDA is alerting patients and healthcare providers about Exactech’s Equinoxe Shoulder System joint replacement devices and possible health risks. The devices were manufactured between 2004 and 2021 and were packaged in defective bags. “The defective bags used to package the Equinoxe Shoulder System devices were missing one of the
Devices
ROi CPS has recalled its Regard Operative Lap P&S Surgical Kit due to the possibility it may not be sterile. The surgical kits were built with a recalled item from a separate Class I recall from Nurse Assist. “Nurse Assist, LLC recalled their 0.9% sodium chloride irrigation
Drugs
FDA has granted Hyloris Pharmaceuticals an orphan drug designation for PTX-252 for the treatment of acute myeloid leukemia (AML). “This product candidate, developed in collaboration with Pleco Therapeutics BV incorporates a novel molecular entity that is a derivative of a known established molecule and is designed to enhance the
Drugs
Reps. Doris Matsui (D-CA) and Larry Buschon (R-IN) have introduced the Mapping America’s Pharmaceutical Supply (MAPS) Act to help the federal government prepare for and mitigate future drug shortages by identifying drug supply chain vulnerabilities. A Matsui news release (includes a link to the full bill text)
Drugs
In recent years, FDA has demonstrated increased interest in regulating “off-label” communications, according to attorney Chia-Feng Lu (Greenberg Traurig). Writing in an online National Law Review post, Lu sees greater risk for medical product firms coming from uncertainty over a recent FDA guidance on communication of scientific information
Biologics
The DC federal court has approved an FDA request to stay its response to a Children’s Health Defense Freedom of Information Act (FOIA) request for records connected with the safety monitoring of Covid-19 vaccines through the VAERS (Vaccine Adverse Event Reporting System) database. But it cut the requested
Drugs
U.S. Reps. Anna G. Eshoo (D-CA), Diana DeGette (D-CO) and Kim Schrier (D-WA) have introduced the Pediatric Cancer Drug Supply Act of 2024, legislation that is intended to ensure there is a stable supply of essential pediatric cancer drugs in the U.S. The bill would
Drugs
CDER says that the majority (45%) of drug Warning Letters issued in fiscal year 2023 cited GMP requirement violations. The next highest category of letters issued (22%) was for misbranding/unapproved drug product violations, according to a just-released Office of Compliance FY 2023 Annual Report. Compared to last year,
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin.” The International Council for Harmonization document is intended to describe risk-based principles and mitigation strategies to assure the viral safety of
Devices
FDA has granted Darmiyan a de novo marketing authorization for its clinical test BrainSee. The software platform combines standard clinical brain MRI and cognitive assessments to generate an objective score that predicts the likelihood of progression from amnestic mild cognitive (aMCI) impairment to Alzheimer's dementia within five years.
Drugs
Fresenius Kabi has recalled its Ivenix Large Volume Pump (LVP) because some units have mechanical issues with the fluid valve pins in the device’s internal housing, which can cause them to not move properly. Instead of working as they should, the pins may impact the side of a sensor,
Drugs
FDA has approved Merck’s Keytruda (pembrolizumab) with chemoradiotherapy (CRT) for treating patients with FIGO 2014 Stage III-IVA cervical cancer. Approval is based on data from the KEYNOTE-A18 (NCT04221945) trial that enrolled 1,060 patients with cervical cancer who had not previously received definitive surgery, radiation, or systemic
Drugs
The Government Accountability Office (GAO) says Congress should consider giving FDA more authority to oversee dietary supplements. The recommendation is in a GAO report that found that 11 of 12 prenatal supplements it tested had at least one nutrient above or below the levels noted on the labels. “This could
Drugs
FDA has accepted for review a Shorla Oncology NDA for SH-105 for treating breast and ovarian cancer. The agency has set a user fee review action target date of 6/29. SH-105 is described as a ready-to-dilute form of a well-established undisclosed drug that has
Drugs
Canadian federal health minister Mark Holland says the plan recently approved by FDA permitting Florida to import some drugs from Canada is a non-starter that will face Canadian government action to prevent any drug shortages for Canadians. The Canadian Broadcasting Corporation (CBC) says Holland said, “There is no way
Drugs
FDA has published the International Council for Harmonization’s Q5A(R2) guidance, Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin. The document describes the evaluation of the viral safety of biotechnology products including viral clearance and testing, and outlines what data should be