Drugs
FDA has released the FDA-483 issued following a 9/15-9/23/21 inspection at OSRX, Inc., a Missoula, MT, producer of sterile drug products. The form contains one observation that the current laminar airflow studies (smoke studies) of the ISO5 laminar airflow workstation were not performed under conditions
Drugs
FDA has published a guidance, Patient-Focused Drug Development: Methods to Identify What is Important to Patients, describing approaches to identifying what is most important to patients concerning their experience as it relates to the burden of disease/condition and burden of treatment. The document is the second in a
FDA Policy/General
Federal Register notice: FDA is classifying the screw sleeve bone fixation device into Class 2 (special controls). The action was taken in response to a Woven Orthopedic Technologies de novo classification request for its OGmend Implant System, which is intended to be implanted in conjunction with a non-resorbable, metallic
Devices
FDA has posted a final guidance entitled “Center for Devices and Radiological Health (CDRH) Appeals Processes” that describes the processes available to outside stakeholders to request additional review of decisions or actions by Center employees. Such individuals can request supervisory review of an action, submit a petition or request a
Devices
Pink Concussions founder and CEO Katherine Snedaker, a social worker, is asking FDA to revoke the 510(k) clearance indication for use for the SyncThink Eye-Sync as an aid in diagnosing concussion. A 2/26 petition says the Eye-Sync product does not provide any addition to sensitivity or
Drugs
Attorney and data scientist Bradley Thompson (Epstein Becker Green) says that although four years ago then-FDA commissioner Scott Gottlieb promised that the agency would release the identifier number (known as the NCT number) assigned by the National Institutes of Health to clinical trials listed online at clinicaltrials.gov, it
Drugs
IQVIA says it appreciates the FDA effort to provide guidance on the use of registry data to support regulatory decision-making for drug and biological products and the agency’s conceptual approach to defining multiple key terms. The firm’s 2/25 letter commented on an FDA draft guidance, Real-
Drugs
FDA has issued three final guidances on cancer clinical trials that agency officials say parallel the goals of President Biden’s effort to renew his 2016 Cancer Moonshot to facilitate continued advancement in cancer prevention, detection, research, and patient care. FDA Oncology Center of Excellence director Richard Pazdur says that
Drugs
FDA has issued Gilead Sciences a complete response letter on its NDA for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor for treating HIV-1 infection in heavily treatment-experienced people with multi-drug resistant HIV-1 infection. The agency cited chemistry, manufacturing and controls issues relating to the
Devices
FDA has issued three safety alerts to warn people not to use three Covid-19 tests because the agency is concerned they could generate false results. Details on the alerts are here: * FDA safety communication about the Celltrion DiaTrust Covid-19 Ag Rapid Test. * FDA safety communication about the SD
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Patient-Focused Drug Development: Methods To Identify What Is Important to Patients.” The document describes how to collect and submit information from patients and caregivers to be used for medical product development and regulatory decision making. To view the
Drugs
Lexicon Pharmaceuticals has voluntarily withdrawn its NDA for sotagliflozin, indicated for reducing the risk of cardiovascular death, hospitalization for heart failure, and urgent visits for heart failure in adult patients with Type 2 diabetes with either worsening heart failure or additional risk factors for heart failure irrespective of left ventricular
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of an Elanco new animal drug application (NADA 093–329) for use of a prolonged-release bolus containing sulfamethazine in cattle because the product is no longer manufactured or marketed. The sponsor requested the action because the product is no longer manufactured or
Drugs
As FDA begins to transition out of the Covid-19 pandemic, CDER Office of Prescription Drug Promotion (OPDP) staff are likely to resume attending in-person medical conferences and trade shows and will presumably have a renewed interest in reviewing materials disseminated and assessing interactions at the booths in these
Drugs
Clinical trial sites that routinely identify issues of potential non-compliance with good clinical practice (GCP) should review corrective actions (e.g., changes to SOPs or training) to make sure they have fully addressed the non-compliance, ORA Office of Bioresearch Monitoring Operations director Chrissy Cochran told a 2/16
Devices
FDA has sent a letter to healthcare professionals that emphasizes the importance of lifelong surveillance, including imaging, for patients with abdominal aortic aneurysm (AAA) endovascular aortic repair (EVAR) using stent graphs. “Regular imaging surveillance, within 30 days of EVAR and annually thereafter, may help identify adverse events such as endoleaks,
Biologics
FDA has extended by three months its review of an AbbVie supplemental BLA for Skyrizi (risankizumab-rzaa) for treating moderate to severe Crohn’s disease in patients 16 years and older. The extension gives the agency additional time to review additional data submitted by AbbVie, including information about the on-
FDA Policy/General
FDA Amends Animal Drug Regs for Approvals 2/25/2022 Federal Register notice: FDA is amending the animal drug regulations to reflect application-related actions for NADAs, ANADAs and conditionally approved NADAs made during 7/2021, 8/2021 and 9/2021. Additionally, the agency is informing the public about the
FDA Policy/General
Avara Pharmaceutical Services has signed an agreement with Pfizer to acquire its Liscate, Italy sterile manufacturing facility. Avara Pharmaceutical Services is a contract manufacturing and technical services company providing both active pharmaceutical ingredient formulation and manufacturing, along with secondary formulation, manufacturing and packaging of small molecule drugs, including highly potent
FDA Policy/General
DEVICES FDA has cleared a bioMérieux 510(k) for the VIDAS 3 immunoassay analyzer. This newest version of the device features enhanced automation, improved traceability and new software capabilities, as well as a quality control program in compliance with laboratory certification standards, the company says. Corvida Medical has received FDA
Drugs
FDA has revised an AstraZeneca emergency use authorization (EUA) for Evusheld (tixagevimab co-packaged with cilgavimab) to change the initial dose for the authorized use as Covid-19 pre-exposure prevention in certain adults and pediatric patients. “Based on the most recent information and data available, Evusheld may be less
FDA Policy/General
Federal Register notice: FDA is amending the animal drug regulations to reflect application-related actions for NADAs, ANADAs and conditionally approved NADAs made during 7/2021, 8/2021 and 9/2021. Additionally, the agency is informing the public about the availability of summaries of the basis of approval and of