FDA Policy/General
Federal Register notice: FDA has published a list of eight information collections that have been approved by OMB. They are: * Agreement for Shipment of Devices for Sterilization * Substances Prohibited fromUse in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed * Clinical Laboratory Improvement Amendments Waiver Applications * Registration and Product
Drugs
CDER says the phased implementation of the reorganization of the Office of New Drugs is well underway, with Phase 2 implementation having started 11/4. A notice says Phase 2 will occur over several weeks and involve selecting leadership for several new divisions, including directors for the Divisions of Pharm/
Drugs
FDA has released the FDA-483 with seven observations issued following an 8/27-9/11 inspection at Innoveix Pharmaceuticals, an Addison, TX, producer of sterile and non-sterile drug products. The inspection observations were: * unprotected product intended to be sterile was exposed to lower than ISO 5 classified aseptic
Drugs
Pfizer CEO Albert Bourta says that payers are trapped and can’t cover biosimilars because they would lose the benefit of rebates offered by the innovator companies. “Unless we resolve this big issue,” he said on a third quarter conference call, “we will never be able to see tremendous progress
Drugs
IQVIA (formerly IMS Health and Quintiles) says an FDA draft guidance on general pharmacology considerations for neonatal studies for drugs and biological products provides a helpful explanation of the agency’s current thinking on the topic. The firm’s comment letter says it strongly advocates that generation of data in
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