FDA Policy/General
Q & A Guide on Biosimilar Development 9/17/2021 Federal Register notice: FDA has made available a final guidance entitled Questions and Answers on Biosimilar Development and the BPCI Act. The document is intended to inform prospective applicants about the development of proposed biosimilars and proposed interchangeable biosimilars. It
FDA Policy/General
Baxter International has acquired two hemostat and sealant products from Mallinckrodt — Recothrom Thrombin topical (recombinant) and Preveleak Surgical Sealant that is used in vascular reconstruction. Under the transaction, Baxter paid an upfront payment of $153 million and agreed to potential contingent payments in the future. H. Lundbeck has agreed to
FDA Policy/General
DEVICES FDA has granted a Roche de novo request to allow the marketing of its Anti-Müllerian (AMH) assay, which the company calls the first approved fully automated AMH test available in the U.S. to help women who are planning to become pregnant or struggling with infertility. The blood
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Questions and Answers on Biosimilar Development and the BPCI Act. The document is intended to inform prospective applicants about the development of proposed biosimilars and proposed interchangeable biosimilars. It also describes FDA’s interpretation of certain statutory requirements added
FDA Policy/General
Federal Register notice: FDA has made available a revised draft guidance for industry entitled Draft Guidance for Ferric Oxyhydroxide. The document provides product-specific recommendations on the design of bioequivalence studies to support ANDAs for ferric oxyhydroxide oral tablets and intravenous injectable products. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision entitled “Biosimilars User Fee Program” (OMB Control Number 0910-0718). For efficiency purposes, the agency is consolidating a related information collection on current user fee commitment goals as set forth in the document “BsUFA Reauthorization Performance Goals and
FDA Policy/General
FDA has released a Bad Ad Quiz so people can test their knowledge about prescription drug promotion and the agency’s Bad Ad Program. The agency says the program helps to ensure that information from prescription drug promotions that healthcare providers may use to inform their assessment of a drug’
FDA Policy/General
FDA says it is creating an Office of Digital Transformation reporting directly to the FDA commissioner to advance the agency’s information technology (IT) transformation with improved data and information technology competencies that enhance agency operations. The new Office of Digital Transformation will house IT, data management, and cybersecurity functions,
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of three NDAs because the application holders have repeatedly failed to file required annual reports. The withdrawn NDA are: * NDA 016401: PolyMedica Industries’ Neopap (acetaminophen) suppositories * NDA 050266: Storz Ophthalmics’ Achromycin (tetracycline hydrochloride ophthalmic ointment, 10 mg/gram * NDA 050268: Storz Ophthalmics’ Achromycin
FDA Policy/General
Federal Register notice: FDA has announced an 11/4 Blood Products Advisory Committee meeting. Panel members are scheduled to hear three updates on the research programs at CBER’s Plasma Derivatives Branch, Laboratory of Cellular Hematology, and Laboratory of Emerging Pathogens. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is consolidating regulatory oversight responsibilities in CBER for certain devices that process autologous human cells, tissues, and cellular and tissue-based products at the point of care where the device output is intended to mediate the intended therapeutic effect. To support this consolidation effort, fat transfer
FDA Policy/General
Allergenic Products Panel to Hear Research Overview 9/10/2021 Federal Register notice: FDA has announced a 10/28 Allergenic Products Advisory Committee meeting. Panel members are scheduled to hear an overview of the research programs in CBER’s Laboratory of Immunobiochemistry. To view the notice, click here. Workshop on
FDA Policy/General
DEVICES FDA has granted 510(k) clearance to Joimax to market its Endoscopic Lumbar Interbody Fusion, or EndoLIF On-Cage implant. According to the company,the implant allows surgeons to use an inter-muscular approach, similar to a mini transforaminal lumbar interbody fusion, into the intervertebral disc, enabling endoscopic-assisted
FDA Policy/General
Federal Register notice: FDA has announced a 10/28 Allergenic Products Advisory Committee meeting. Panel members are scheduled to hear an overview of the research programs in CBER’s Laboratory of Immunobiochemistry. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is reopening the comment period for public scoping on the environmental impact statement described in the notice entitled “Intent To Prepare an Environmental Impact Statement for Certain Sunscreen Drug Products for Over-the-Counter Use” that appeared in a 5/13 notice. Electronic or written comments
Drugs
CDER’s Office of Prescription Drug Promotion (OPDP) has proposed a new study to examine whether disclosures in direct-to-consumer (DTC) and healthcare provider-targeted advertising could support allowing clinical benefit information based on a secondary endpoint reported in a product’s approved labeling (secondary claim) to be included
FDA Policy/General
Federal Register notice: FDA has announced a public workshop entitled “Reconsidering Mandatory Opioid Prescriber Education Through a Risk Evaluation and Mitigation Strategy (REMS) in an Evolving Opioid Crisis.” Convened by the Duke-Margolis Center for Health Policy, the workshop is intended to give stakeholders an opportunity to provide input on
FDA Policy/General
Former FDA commissioner Stephen Hahn has joined YourBio Health, described as the developer of the first painless pushbutton blood collection device, as its interim chief medical officer. Hahn is also the chief medical officer for the Preemptive Medicine and Health Security Initiative at Flagship Pioneering at large, according to a
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled S12 Nonclinical Biodistribution Considerations for Gene Therapy Products. The International Council for Harmonization document provides recommendations for the conduct and overall design of nonclinical biodistribution (BD) studies for gene therapy products. It also offers considerations for interpreting and applying
FDA Policy/General
Federal Register notice: FDA is reopening the comment period on a draft guidance entitled ICH Q12: Implementation Considerations for FDA-Regulated Products. Comments can be submitted until 10/12. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Generic Clearance for Quantitative Testing for the Development of FDA Communications” (OMB Control Number 0910-0865). The collection allows FDA to use quantitative social/behavioral science data collection techniques (i.e., surveys and experimental studies) to test
FDA Policy/General
Federal Register notice: FDA is requesting nominations for members to serve on the Tobacco Products Scientific Advisory Committee. Nomination should be submitted by 11/8. To view the notice, click here.