Devices
Writing in an FDA Voice blog post, CDRH director Jeffrey Shuren says that in the 40 years since Congress passed the Medical Device Amendments, what started out as a mom-and-pop industry “has transformed into a world of sophisticated software, algorithms, miniaturization, combination products, wearable sensors, non-invasive procedures
Drugs
FDA says its FDA Adverse Event Reporting System regional implementation specifications developed for the International Conference on Harmonization are now available. A 6/23 Federal Register notice containing a link to the guidance says that the agency is making the technical specifications document available to assist interested parties in electronically
Drugs
A National Institutes of Health (NIH) advisory committee approved 6/21 a proposal to use the CRISPR genome-editing technology in a human trial to help augment cancer therapies that rely on enlisting a patient’s T cells. The journal Nature reports that the NIH Recombinant DNA Research Advisory Committee
Drugs
Why does FDA turn its head when pharmaceutical companies publish glowing reports in medical journals about their drugs and clinical trial data, particularly when it goes against the agency’s own statistical analyses it performed when reviewing data in a marketing application? That is the question Duke University Medical Center
Drugs
AdvaMed says it would like to better understand the relationship between an FDA draft guidance on human factor studies and related clinical study considerations in combination product design and development and a recently issued guidance on applying human factors and usability engineering to medical devices. Commenting on the new draft,
Drugs
FDA and the European Medicines Agency (EMA) have expanded their international collaboration by setting up a new forum or “cluster” on patient engagement. The working group will teleconference several times a year to share experiences and best practices on the way the two agencies involve patients in drug development, evaluation
Drugs
Two drug compounding pharmacists from Alabama have been sentenced to 12 and 10 months in prison for their roles in distributing adulterated drugs that were compounded at the now-defunct Advanced Specialty Pharmacy doing business as Meds IV. David Allen, the former pharmacist-in-charge of Meds IV, and William
FDA Policy/General
Federal Register Withdrawal of notice: FDA withdraws a 6/2 Federal Register notice, which announced that a proposed collection of information, “Guidance for Industry on Nonproprietary Naming of Biological Products,” had been submitted to the Office of Management and Budget. To view this notice, click here.
FDA Policy/General
Federal Register Final rule: FDA is amending certain regulations on donor eligibility, including the screening and testing of donors of particular human cells, tissues, and cellular and tissue-based products, and related labeling. This final rule is in response to the agency’s enhanced understanding in this area and in
Drugs
FDA says it has approved an sNDA modifying the Risk Evaluation Mitigation Strategy (REMS) for Lundbeck’s anticonvulsant Sabril (vigabatrin) by removing some REMS elements. An agency statement says that FDA determined that although the risk of vision loss with Sabril still exists, the REMS should be modified to remove
Devices
FDA has appointed former Anika Therapeutics chief scientific officer John Sheets as CDRH Office of Device Evaluation director effective 6/1. Sheets replaces former director Christy Foreman, who stepped down in 2014 to accept a new position at FDA’s Center for Tobacco Products. CDRH’s deputy director for science
Drugs
An FDA inspection at Burzynski Manufacturing Facility, Stafford, TX, found significant violations of current good manufacturing practice (CGMP) for finished pharmaceuticals, according to a 6/13 Warning Letter. Stanislaw Burzynski has been the subject of FDA Warning Letters and other enforcement actions at his Houston clinic since at least 2009.
Devices
The federal government has filed an amicus brief with the 1st Circuit Court of Appeals to argue the position that “fraud in the inducement” is a potentially viable theory of False Claims Act (FCA) liability. The brief was filed in an appeal of a Massachusetts federal court whistleblower suit against
FDA Policy/General
Federal Register Notice: FDA has determined the regulatory review period for Xofigo is 1,945 days for extending a patent which claims the human drug product. FDA has approved for marketing the human drug product Xofigo (radium 223 dichloride) for treating patients with castration-resistant prostate cancer, symptomatic bone metastases
FDA Policy/General
Final order: FDA is classifying the gynecologic laparoscopic power morcellation containment system into Class 2 (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the gynecologic laparoscopic power morcellation containment system’s classification. To
FDA Policy/General
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. American Pure Whey, LLC Raleigh, NC (5/24). Inspected New Bern, NC facility 9/15-18/15. CGMP deviations, adulterated, misbranded: The American Pure Whey 100% Pure Whey Matrix
Drugs
Visium Asset Management partner Sanjay Valvani, who was recently arrested and charged with insider trading in a scheme that involved a former FDA Office of Generic Drugs official (see earlier story), has been found dead in an apparent suicide at his New York home. Former FDA Office of Generic Drugs
Drugs
The National Institutes of Health (NIH) says that its new Policy on the Use of a Single Institutional Review Board (IRB) for Multi-Site Research “sets the expectation that multi-site studies conducting the same protocol use a single IRB to carry out the ethical review of the proposed research.
Devices
A 11/30/15-2/12/16 FDA inspection at Tyrx, Inc., Monmouth Junction, NJ, found Quality System Regulation violations in the firm’s manufacturing of the Tyrx antibacterial envelope, Tyrx antibacterial absorbable envelope, and the Tyrx neuro antibacterial absorbable envelope, according to a 6/2 Warning Letter from the
Drugs
In a decision that could hurt the drug and biologic industry over intellectual property rights, the U.S. Supreme Court has decided Cuozzo Speed Technologies, Inc. v. Lee, holding that, in an inter partes review, the Patent and Trademark Office (PTO) may give a patent claim its broadest reasonable interpretation
FDA Policy/General
A Heritage Foundation legal memorandum says there can be no doubt that “the existing FDA regulatory system is less than satisfactory and requires substantial and timely reform. Now is the time to begin seriously to explore the contours of such reform.” The paper says that much of the discussion about
Drugs
Pharmaceutical Research and Manufacturers of America and the Biotechnology Industry Organization say they share FDA’s goal of ensuring adequate study of and labeling for use of drug and biological products in children. In a comment to an agency draft guidance on the content and process for submitting initial pediatric