FDA Policy/General
Federal Register Notice: FDA is making available a guidance for industry entitled Requirements for Transactions with First Responders under Section 582 of the Federal Food, Drug, and Cosmetic Act — Compliance Policy. It describes the agency’s compliance policy on certain requirements in the FD&C Act for trading partners
Drugs
With apologies for missing our deadline on last week’s report about a Warning Letter that took almost 14 months to be issued to Myerlee Pharmacy, Fort Myers, FL, FDA’s Office of Media Affairs 2/29 obliquely provided an indirect explanation that accepted no responsibility for the shock the
FDA Policy/General
A Western Texas jury has found Vascular Solutions and its CEO Howard Root not guilty on all federal charges concerning alleged off-label promotions of the Vari-Lase Short Kit. Senior U.S. District judge Royce Lamberth has entered an order dismissing the case that is final and not subject
Devices
Abbott has begun a Class 1 recall of its MitraClip Delivery System to reinforce the proper procedures used to operate and deploy the device. The company says it has received nine Medical Device Reports where the user was unable to separate the implantable Clip from the delivery system. “Abbott’s
Drugs
A Washington Legal Foundation backgrounder dismisses plaintiffs’ bar actions to weaken medical device preemption. Authored by Mayer Brown partner Andrew Tauber, the backgrounder notes that the bar’s most recent effort argues that recent decisions involving First Amendment protection for commercial speech have undermined the basis for federal preemption. “The
FDA Policy/General
Federal Register Notice: FDA is making available a draft FDA Tribal Consultation Policy and is establishing a docket to receive comments on the document. Its purpose is to establish clear policies to further the government-to-government relationship between FDA and American Indian and Alaskan native tribes and facilitate tribal
FDA Policy/General
Federal Register Notice: FDA’s collection of information entitled “Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products and Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions,” has been approved by the Office of
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information, “Electronic Submission of Food and Drug Administration Adverse Event Reports and Other Safety Information Using the Electronic Submission Gateway and the Safety Reporting Portal — 21 CFR 310.305, 314.80, 314.98, 314.540, 514.80, 600.80, 1271.350 and
FDA Policy/General
Federal Register Notice: FDA’s collection of information entitled “Food and Drug Administration’s Research and Evaluation Survey for the Public Education Campaign on Tobacco among LGBT (RESPECT),” has been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995. To view this notice, click
Devices
FDA has ordered Bayer to conduct a postmarket surveillance study on its controversial birth control device Essure as part of its just-released safety review of the product. The study should be designed to determine heightened risks for particular women, the agency says. Additionally, it has released a draft guidance
FDA Policy/General
After seven years in the job, FDA Center for Veterinary Medicine (CVM) director Bernadette Dunham announced 2/29 that she is leaving the agency in April to participate in a One Health collaborative effort between the Milken Institute School of Public Health at the George Washington University and FDA. An
Drugs
FDA has made available $2 million in research grants to fund natural history studies in rare diseases. “The goal of the program is to help characterize the natural history of rare diseases, identify subpopulations, and develop and/or validate clinical outcome measures, biomarkers and companion diagnostics,” an FDA notice says.
Drugs
FDA has published a new guidance on “Requirements for Transactions with First Responders under Section 582 of the Federal Food, Drug, and Cosmetic Act — Compliance Policy” that describes FDA’s compliance policy regarding certain requirements in the Food, Drug, and Cosmetic Act for trading partners engaged in transactions with first
FDA Policy/General
BIOLOGICS FDA has approved a Genentech supplemental BLA for Gazyva (obinutuzumab) plus bendamustine chemotherapy followed by Gazyva alone as a new treatment for people with follicular lymphoma who did not respond to a Rituxan (rituximab)-containing regimen, or whose follicular lymphoma returned after such treatment. Follicular lymphoma is the most
Drugs
FDA has approved Allergan’s Aczone (dapsone) gel, 7.5%, a new prescription topical treatment for acne in patients 12 years of age and older. According to the company, the gel treats both inflammatory and non-inflammatory acne in a once-a-day application with a new pump delivery system.
FDA Policy/General
Federal Register Notice: FDA is seeking comments on the information collection provisions of the guidance entitled Tobacco Retailer Training Programs. Comments should be submitted by 4/26. To view this notice, click here.
FDA Policy/General
Federal Register Notice: The FDA commissioner is renewing the Gastrointestinal Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 3/3/18. To view this notice, click here.
Drugs
Cellceutix Corp. has submitted a Special Protocol Assessment request and a final protocol to FDA for a Phase 3 clinical trial of its antibiotic, Brilacidin, for treating acute bacterial skin and skin structure infection (ABSSSI) caused by Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus. The company says it met
Devices
The Clinical Decision Support Coalition says FDA is not providing “regulatory clarity” on clinical decision support (CDS) software. A 2/25 white paper from the group says that the agency had identified CDS software guidance a top priority in its 2015 regulatory agenda, but the agency has yet to define
Devices
Former Siemens Healthcare Diagnostics quality management vice president Robin Newman has been selected as CDRH Office of Compliance director, effective 2/22. Newman replaces Steve Silverman, who left the agency a year ago to join McKinsey & Company as a senior expert, medical product quality, compliance, and remediation. Newman has
Biologics
FDA has approved a Genentech supplemental BLA for Gazyva (obinutuzumab) plus bendamustine chemotherapy followed by Gazyva alone as a new treatment for people with follicular lymphoma who did not respond to a Rituxan (rituximab)-containing regimen, or whose follicular lymphoma returned after such treatment. Follicular lymphoma is the most common
Drugs
FDA has announced a planned “National Direct-to-Consumer (DTC) Advertising Survey” to obtain updated insights on consumer experiences with and attitudes towards DTC prescription drug promotion. The agency last surveyed patients about their experiences with and attitudes toward DTC advertising in 2002, according to a notice seeking comments on