FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance entitled Display Devices for Diagnostic Radiology. It provides recommendations for the types of information that should be provided in premarket notification submissions (510(k)) for display devices intended for diagnostic radiology with the assigned product code PGY. This guidance, when
FDA Policy/General
Federal Register Notice: FDA is announcing Booz Allen Hamilton’s final evaluation report submitted as part of their independent assessment of the process for the review of medical device submissions. To view this notice, click here.
FDA Policy/General
Federal Register Notice: CDER is announcing the continuation of the Regulatory Project Management Site Tours and Regulatory Interaction Program. The Center is inviting pharmaceutical companies interested in participating in this program to contact CDER. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA is publishing a list of PMAs that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the Agency's Division of Dockets Management. To view this notice, click
FDA Policy/General
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. ABC Productions Redondo Beach, CA (2/4). Reviewed Web site at www.calistores.com and www.cbdy.com in January. Misbranded: The claims on the Web sites establish that
FDA Policy/General
BIOLOGICS CBER Seeks Participants for Site Training Program Federal Register Notice: CBER is inviting biologics facilities to contact the Center for more information on participating in its Regulatory Site Visit Training Program (RSVP). This training program is intended to give CBER regulatory review, compliance, and other relevant staff an opportunity
FDA Policy/General
FDA says that in Fiscal Year 2015 it had one product seizure, 21 injunctions, 17,232 Warning Letters, 2,789 recall events, 9,178 recalled products, and 14 drug product debarments. The agency’s summary of enforcement statistics breaks down each of those categories. It shows, for instance, that seizures
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information, “Guidance on Meetings with Industry and Investigators on the Research and Development of Tobacco Products,” has been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995. To view this notice, click
FDA Policy/General
Federal Register Notice: FDA’s collection of information entitled “Postmarketing Adverse Drug Experience Reporting” has been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA’s collection of information entitled “Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application,” has been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance entitled List of Highest Priority Devices for Human Factors Review. The agency aims to inform medical device manufacturers on which device types should have human factors data included in premarket submissions. FDA believes these device types have clear potential for
FDA Policy/General
Federal Register Notice: FDA makes available a draft guidance for industry and FDA staff entitled Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices. It will describe the agency’s intent not to enforce, before 9/24/21, the prohibition against providing National
FDA Policy/General
Three Kaye Scholer attorneys say that FDA regulatory experts often testify in court cases and can serve a valuable purpose in helping juries understand regulations and how companies interact with the agency. Writing in an online post, the three say that sometimes parties, often plaintiffs, try to use regulatory experts
FDA Policy/General
Federal Register Notice: FDA’s collection of information entitled “Biosimilar User Fee Cover Sheet; Form FDA 3792,” has been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA is making available a guidance entitled Applying Human Factors and Usability Engineering to Medical Devices. Its purpose is to assist industry in following appropriate human factors and usability engineering processes to maximize the likelihood that new medical devices will be safe and effective for the intended
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance for industry and FDA staff entitled Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development. It provides guidance on the underlying principles of human factors studies during the development of combination products. To download this
FDA Policy/General
Federal Register Notice: CBER is inviting biologics facilities to contact the Center for more information on participating in its Regulatory Site Visit Training Program (RSVP). This training program is intended to give CBER regulatory review, compliance, and other relevant staff an opportunity to visit biologics facilities to allow CBER staff
FDA Policy/General
Federal Register Notice: FDA’s collection of information entitled “General Licensing Provisions; Section 351(k) Biosimilar Applications” has been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995. To view this notice, click here.
FDA Policy/General
Positive feelings produced by images in direct-to-consumer drug ads can promote favorable beliefs about the drugs, according to research published online in Bioethical Inquiry (subscription or purchase required). Researchers from the U.S. and Australia say that their work shows that pairing a hypothetical influenza prescription medicine with
Drugs
Yale Law School professor Amy Kapczynski says that a federal court decision in a suit brought by Amarin against FDA over dissemination of off-label information on its Vascepa in effect replaces drug regulators with judges, whose expertise in science and medical research varies considerably, when off-label promotion is
FDA Policy/General
Federal Register Notice: FDA seeks comments on the reporting requirements for submission and listing of patent information associated with a new drug application, an amendment, or a supplement. Comments should be submitted by 4/4. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA’s collection of information entitled “Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees” has been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995. To view this notice, click here.