FDA Policy/General
Federal Register Notice: FDA is asking for comments on an OMB submission seeking an information collection extension on using focus groups about drug products. The agency says focus groups serve a narrowly defined need for direct and informal opinion on a specific topic and as a qualitative research tool. It
FDA Policy/General
Federal Register Notice: FDA has established a public docket to receive input on a new CDRH program on “Patient and Care-partner Connection.” Under the program, CDRH will partner with patient organizations to provide a means for Center staff to formally engage with patients and care-partners to gain perspective
FDA Policy/General
Federal Register Notice: FDA has made available a guidance on “Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes.” The document is intended to assist sponsors who intend to submit an IDE to conduct clinical trials on medical devices targeting neurological disease progression
FDA Policy/General
FDA commissioner Robert Califf and CMS administrator Andrew Slavitt offer their perspectives on the two agencies’ changing approaches and evidence standards for admitting products to the market and Medicare paying for them. Writing in a new JAMA viewpoint article, the two say that “changes in the organization of health care
FDA Policy/General
ANIMAL DRUGS Guide on Animal Drug User Fees/Waivers Federal Register Notice: FDA has made available a draft revised guidance on “Animal Drug User Fees and Fee Waivers and Reductions.” The document describes the types of fees FDA is authorized to collect under the Animal Drug User Fee Act of
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) that a Spanish-language video produced by Supernus Pharmaceuticals to influence key opinion leaders about its Oxtellar XR (oxcarbazepine) extended-release tablet for oral use makes false or misleading claims about the drug’s risks and provides evidence that it is intended
FDA Policy/General
The FDA Risk Communication Advisory Committee meets 11/7 to discuss and make recommendations on the agency’s draft Strategic Plan for Risk Communication and Health Literacy, intended to clarify how FDA can communicate the benefits and risks of regulated products to target audiences more effectively and thus promote better
FDA Policy/General
HealthNewsReview.org, which last year began reviewing healthcare PR news releases from a variety of sources on a 10-criteria system, gives a grade of “C” to the five FDA releases it has looked at. The good news for the agency, the report says, is that the releases generally scored
FDA Policy/General
Federal Register Notice. FDA has announced the issuance of two emergency use authorizations (EUAs) for in vitro diagnostic devices for detecting the Zika virus in response to the Zika virus outbreak. The EUAs were issued to Vela Diagnostics for its Sentosa test and Arup Laboratories for its Zika Virus Detection
FDA Policy/General
Federal Register Notice: FDA is asking for comments on an OMB submission seeking an information collection extension on the guidance “Planning for the Effects of High Absenteeism To Ensure Availability of Medically Necessary Drug Products.” The document recommends that manufacturers of drug and therapeutic biological products and manufacturers of raw
FDA Policy/General
Federal Register Notice: FDA is asking for comments on a request for OMB to extend an information collection on “The Protection of Human Subjects: Informed Consent; Institutional Review Boards.” The extension request applies to exceptions from informed consent requirements for emergency research, the elements of informed consent, and documentation of
FDA Policy/General
Federal Register Notice: FDA has announced a 11/5 Science Board advisory committee meeting at the agency’s White Oak campus (Silver Spring, MD). The board will receive updates on CBER’s strategic goals for regulatory science, FDA’s Opioid Action Plan and the Bovine Heparin Initiative. It will also
FDA Policy/General
Federal Register Notice: FDA has made available a draft revised guidance on “Animal Drug User Fees and Fee Waivers and Reductions.” The document describes the types of fees FDA is authorized to collect under the Animal Drug User Fee Act of 2003, as amended, and how to request waivers and
FDA Policy/General
Recent comments on an FDA proposal to study use of animation in direct-to-consumer advertising highlight concerns about the study as well as its potential benefits. The Advertising Coalition urges the agency to be aware of Supreme Court protections for commercial speech, including advertising. Its letter particularly cites a
FDA Policy/General
Federal Register Notice: FDA is asking for comments on an OMB submission seeking to extend an information collection related to a guidance on “Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims.” To view the notice, click here.
FDA Policy/General
Federal Register Notice: FDA is asking for comments on an OMB submission seeking to extend an information collection on recordkeeping requirements related to the agency’s regulations on Human Tissue Intended for Transplantation (21 CFR Part 1270). Under the regulations, facilities are required to meet provisions intended to ensure appropriate
FDA Policy/General
An online World of DTC Marketing blog post by marketing consultant Richard Meyer says that consumers and patients don’t want a social media relationship with drug companies. Responding to changes Facebook is making to become more attractive to drug companies, the author says they won’t work because they
FDA Policy/General
Former CDRH senior executive Jonathan Bernstein describes in a Linkedin post his four-step plan for improving FDA, and especially the Center where he worked. His recommendations are: * find the innovators within the agency, insulate them from bureaucracy, legitimize their work, and empower these teams; * reorganize reviewer assignments to align
FDA Policy/General
Federal Register Notice: FDA is asking for comments on a submission to OMB seeking to extend an information collection on “Patent Term Restoration Due Diligence Petitions.” Such petition are filed to request revisions to the regulatory review period used to determine patent term restorations. For 2013, 2014 and 2015, a
FDA Policy/General
Federal Register Notice: FDA is asking for comments on a submission to OMB seeking to extend the recordkeeping requirements for institutional review boards. To view the notice, click here.
FDA Policy/General
Federal Register Notice: FDA has extended the comment period for the Medical Device User Fee Amendments reauthorization draft recommendations that were announced in a 10/7 notice. Comments now can be submitted by 11/28. To view the notice, click here.
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Beijing Taiyang Pharmaceutical Industry Co. Beijing, China (10/19): FDA attempted to inspect the firm 11/2015 and the firm limited the inspection. Agency investigators observed through a window