Devices
FDA says it is considering a master file pilot program for PMA holders whose approved devices are sterilized using radiation, including gamma radiation. An agency notice says the agency is considering such a pilot program due to global supply chain constraints and to support sterilization supply chain resiliency. “If implemented,
FDA Policy/General
Federal Register notice: FDA is publishing a list of PMAs that have been approved from 1/1/2021 through 2/14/2022. The list is intended to inform the public about the availability of safety and effectiveness summaries of approved PMAs through the Internet. To view the notice, click here.
Drugs
FDA has approved a Novo Nordisk NDA for Wegovy (semaglutide) injection (2.4 mg once weekly) for treating adults with obesity or who are overweight with at least one weight-related condition (e.g., high blood pressure, Type 2 diabetes, or high cholesterol). FDA says the subcutaneous injection is the
Drugs
FDA has released the FDA-483 issued to Nephron Sterile Compounding Center, a West Columbia, SC, outsourcing facility, with seven observations from a 3/28-4/20 inspection. The specific observations were: * failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says an Althera Pharmaceuticals professional communications piece for Roszet (rosuvastatin and ezetimibe) tablets makes false or misleading claims and representations about the risks and efficacy of Roszet. A 6/2 Untitled Letter says the violations are concerning from a public health perspective
Drugs
Sens. Susan Collins (R-ME), Tim Kaine (D-VA), Maggie Hassan (D-NH), and Rob Portman (R-OH) are introducing the Interchangeable Biologics Clarity Act that they say will strengthen the FDA approval process pipeline and increase transparency for critical medicines, thus lowering costs and increasing availability of key medications.
Drugs
A former employee at Eli Lilly has filed a wrongful termination suit against the pharmaceutical manufacturer, claiming she was fired in retaliation for allegedly raising issues about GMP problems and data falsification involving top-selling Type 2 diabetes drug Trulicity. The plaintiff, Amrit Mula, was terminated in 2019 after bringing
Drugs
CDER Office of Drug Security, Integrity, and Response director Leigh Verbois says the agency will continue to revise and update the APEC (Asia Pacific Economic Cooperation) toolkit to assist in drug supply chain integrity. Interviewed on an Rx 360 podcast, Verbois said that as the toolkit was developed, it became
Drugs
A California federal judge has approved a $10.8 million settlement between Bristol-Myers Squibb and direct buyers of HIV medication who claimed the company engaged in anti-competitive conduct to block generic competition and artificially inflate medication prices. The case involves KPH, a retail and online pharmacy operator, that
Biologics
FDA says it is challenged to determine the overall benefit-risk profile of Bluebird bio’s eli-cel (elivaldogene autotemcel) gene therapy, indicated for treating patients less than 18 years of age with early cerebral adrenoleukodystrophy who do not have an available and willing human leukocyte antigen-matched sibling hematopoietic
Biologics
FDA’s Vaccines and Related Biological Products Advisory Committee 6/7 voted unanimously (21 to 0) to recommend that the agency grant Novavax an emergency use authorization for its Covid-19 vaccine and its use in individuals 18 years of age and older. FDA’s briefing document said vaccine efficacy
Devices
After more than 13 years at the FDA, CDRH Office of Device Evaluation regulatory advisor Joshua Silverstein announced 6/3 that he left the agency for an undisclosed private sector job. Prior to spending almost six years as a regulatory advisor, Silverstein served as a Medical Device Reporting analyst and
Drugs
A 10/5-10/19/21 FDA inspection at the Aire-Master of America drug manufacturing facility in Nixa, MO, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs and other violations. A 5/23 Warning Letter says specific violations were: * failing to establish laboratory controls
Devices
CDRH director Jeff Shuren says as the Covid-19 health emergency subsides he hopes the Center can incorporate more regulatory flexibility, which was critical in getting numerous products to market during the public health emergency. He said this during an online FDA update about life after the pandemic and what
Biologics
FDA has approved a GSK BLA for Priorix (measles, mumps and rubella vaccine) for use in individuals 12 months of age and older. The company notes that recently measles outbreaks have been rising in the U.S. and globally, “with more than 400,000 cases confirmed in 2019, reversing decades
Biologics
Bristol Myers Squibb has withdrawn a supplemental BLA for Reblozyl (luspatercept-aamt) for treating anemia in adults with non-transfusion dependent (NTD) beta thalassemia. The company said it could not appropriately address FDA’s questions about the benefit-risk profile of Reblozyl in the patient population based on the current
Drugs
The Washington State Supreme Court ruled 6/2 that the state does not have any drug direct-to-consumer advertising exception requiring pharmaceutical marketers to specifically warn patients about potential adverse events when drug products are advertised directly to consumers. When a drug marketer advertises its products directly to consumers,
Devices
FDA has classified as Class 1 a Philips Respironics recall of all V60 and V60 Plus ventilators because an internal power fluctuation may cause the ventilator to shut down unintentionally either with or without any visible or audible alarms. “The power fluctuation causes a reboot of the backup alarm controller,
FDA Policy/General
Federal Register notice: FDA is withdrawing its guidance entitled “Effects of the Covid-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices — Questions and Answers (Revised).” The document was issued 6/2020 and it now is being withdrawn because the conditions that created the need
Drugs
Drug companies that receive complete response letters on their submissions cannot circumvent the agency’s hearing process to petition courts for redress. So says the Washington, DC Court of Appeals in a 6/3 decision that rejected a Nostrum Pharmaceuticals request for the court to hear arguments on the company’
Biologics
An FDA advisory committee briefing document says that Novavax’s Covid-19 vaccine’s two-dose primary series demonstrated significant efficacy, but it also showed similar risk signals seen with other Covid vaccines, such as myocarditis/pericarditis. The agency’s Vaccines and Related Biological Products Advisory Committee is being convened
Devices
FDA has released a final guidance entitled “Electromagnetic Compatibility (EMC)of Medical Devices” that offers the agency’s current thinking on recommended information that should be provided in a premarket submission to demonstrate EMC for electrically powered medical devices and medical devices with electrical or electronic functions. The document says