Drugs
The CDER Office of Hematology and Oncology Products (OHOP) has been reorganized as the Office of Oncologic Diseases (OOD). An agency announcement says that OHOP director Richard Pazdur has been named acting director of OOD. Pazdur also directs the FDA Oncology Center of Excellence that was established in 2017 to
Drugs
FDA has posted on its Web site a draft document, “Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA Staff,” as required by the 21st Century Cures Act. The document was released for comment within the next 60 days. In an executive summary, FDA says the draft
FDA Policy/General
The Senate Health, Education, Labor & Pensions Committee has scheduled an 11/20 confirmation hearing for FDA commissioner nominee Stephen Hahn. President Trump nominated the MD Anderson chief medical officer 11/1, the same day former acting commissioner Ned Sharpless was ordered back to his previous position as National Cancer
Drugs
FDA has approved Sandoz’s Ziextenzo (pegfilgrastim-bmez), a biosimilar to Amgen’s Neulasta (pegfilgrastim) for decreasing the incidence of infection, as manifested by febrile neutropenia (low white blood cell count with a fever), in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant
Devices
FDA has cleared a 270Surgical Ltd. 510(k) for its SurroundScope System, which the company describes as the first laparoscopic camera system to offer up to 270-degree field-of-view (FoV). The device was designed and developed to address restricted FoV. The company says that most laparoscopes operate under
Drugs
Six CDER staff members say that in the Center’s Office of Hematology and Oncology Products, less than 10% of INDs went on hold or were withdrawn within the 30-day safety review period. In an article to be published in Regulatory Toxicology and Pharmacology, the researchers report that of
Devices
FDA has launched a new Web page entitled “Ask a Question About Digital Health Regulatory Policies” that encourages firms to inquire about the agency’s current policies on digital health products and providing informal feedback on the possible regulatory status of products in development. Examples of digital health products include
FDA Policy/General
Federal Register notice: FDA is seeking industry organizations to participate in selecting a nonvoting industry representative to serve on CBER’s Allergenic Products Advisory Committee. A nominee may either be self-nominated or nominated by an organization. Industry organizations interested in participating must send a letter stating that interest to
Drugs
An FDA 5/7-5/10 inspection at Bingbing Pharmaceutical Co., Hubei, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a just-released 10/3 Warning Letter. Specific violations were: * failing to maintain written production, control, or distribution records specifically associated with
Drugs
A lengthy Kaiser Health News online story details instances in which FDA has approved branded drugs for marketing despite manufacturing issues raised by agency inspectors. The story says the pressure on the agency to get innovative drugs to market quickly is considerable, because they offer new treatments for desperate patients
Drugs
A McKinsey white paper says a “holistic” transformation of the drug development process could result in accelerating the development timeline by 500 days and reducing cost by 25%. “While there is no silver bullet,” the report says, “drug developers can make a concerted effort to apply and integrate multiple innovations
Drugs
FDA has awarded AnaBios an “Indefinite Delivery, Indefinite Quantity” contract to access its adult human primary tissues and cardiomyocytes from organ donors to assess drug safety related to cardiac function. The company says it has worked for a decade to develop a translational ex-vivo human heart platform. “We anticipate
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says it wants to do research to assess terms and phrases commonly used in prescription drug promotion. A Federal Register notice says the research will look at how consumers and primary care doctors interpret these expressions. It will look at both how
Devices
FDA has cleared a de novo marketing request from Vela Diagnostics USA for its Sentosa SQ HIV Genotyping Assay for detecting human immunodeficiency virus (HIV) Type-1 drug resistance mutations using next generation sequencing (NGS) technology. The assay is the first HIV drug resistance assay that uses NGS technology. The
Devices
AdvaMed says that an FDA draft guidance on testing and labeling medical devices for safety in the magnetic resonance environment could benefit from having more example devices added to the scope section due to the large number of devices affected by the guidance. The comment letter also says it would
Devices
FDA says the Medtronic recall of its MiniMed insulin pumps due to potential cybersecurity risks is Class 1. An agency safety alert says an unauthorized person could potentially record and replay the wireless communication between the remote and the pump. Such a person could then instruct the pump to either
Devices
Sens. Elizabeth Warren (D-MA) and Patty Murray (D-WA) say they were “disappointed” to learn that FDA no longer fully stands by a commitment made by former commissioner Scott Gottlieb to not use a conditional approval pathway for human medical products. In an 11/4 letter to FDA acting
FDA Policy/General
FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below: Bingbing Pharmaceutical, Shiyan Shi Hubei Sheng, China (10/3): FDA inspected the firm in May and cited significant GMP violations for finished
Devices
Abbott has recalled its CentriMag Acute Circulatory Support System due to a calibration system error. The device is intended to pump blood through a patient for up to six hours during open heart procedures. It also provides temporary blood circulatory support for up to 30 days for patients in cardiogenic
Drugs
A recent FDA-requested clinical trial did not alleviate an “overall survival (OS) trend” that the agency was concerned with in an earlier Aveo Oncology study of tivozanib in highly refractory metastatic renal cell carcinoma (RCC) patients, according to a company update. FDA told the company that it was premature
Drugs
Aquestive Therapeutics, which is testing Libervant (diazepam) buccal oral film for seizure clusters, is asking FDA to stay approval of Neurelis’ 505(b)(2) NDA for Valtoco (diazepam intranasal solution) until additional clinical studies have been conducted that would allow for adequate labeling as requested by Aquestive. An Aquestive 11/
Drugs
Tonix Pharmaceuticals says that for its Phase 3 study of Tonmya (cyclobenzaprine sublingual tablets) to treat post-traumatic stress disorder (PTSD), the timing of the primary endpoint analysis has been changed from week 4 to week 12. The company also says it plans to add an interim analysis that allows