FDA Policy/General
Federal Register Notice: FDA is making available a guidance for industry entitled: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products. It provides establishments that make donor eligibility determinations for donors of
FDA Policy/General
Federal Register Notice: FDA will hold a meeting of the Pediatric Advisory Committee 9/14, from 8 a.m. to 5:30 p.m. at DoubleTree by Hilton Hotel Bethesda-Washington DC, 8120 Wisconsin Ave., Bethesda, MD. The panel will discuss pediatric-focused safety reviews, as mandated by the Best
FDA Policy/General
Federal Register Final rule: FDA is issuing a final rule that amends and clarifies the criteria in its regulations for when the use of a substance in food for humans or animals is not subject to the premarket approval requirements of the Federal Food, Drug, and Cosmetic Act because the
FDA Policy/General
FDA’s Center for Veterinary Medicine has approved Leawood, KS-based Arata Therapeutics’ Nocita (bupivacaine liposome injectable suspension) to provides post-operative pain relief for knee surgery in dogs. According to an 8/16 agency news release, the drug is a liposome formulation of bupivacaine, an amide local anesthetic that
FDA Policy/General
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. A.R.C.O.S. Srl Travagliato, Brescia, Italy (8/3) Inspected 4/4-6. QSR deviations, adulterated: The firm does not have written design control procedures, and has
FDA Policy/General
FDA has approved an Aratana Therapeutics’ Nocita (bupivacaine liposome injectable suspension) as a local post-operative analgesia for cranial cruciate ligament surgery in dogs. Nocita is a long-acting, local anesthetic that lasts up to 72 hours post-surgery by releasing bupivacaine over time from multi-vesicular liposomes deposited in
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information, “Applications for FDA Approval To Market a New Drug: Patent Submission and Listing Requirements and Application of 30-Month Stays on Approval of Abbreviated New Drug Applications Certifying That a Patent Claiming a Drug Is Invalid or Will Not Be Infringed,
FDA Policy/General
Federal Register Notice: FDA is making available a guidance entitled Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery. These devices are designed to cut and/or remove tissue and control bleeding through the use of high-frequency electrical current. For the purpose of this guidance, electrosurgical devices
FDA Policy/General
Federal Register Notice: FDA is making available a guidance entitled Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery. FDA has developed this guidance document to assist industry in preparing premarket notification (510(k)) submissions for bipolar electrosurgical vessel sealers intended for use in general surgery.
FDA Policy/General
Federal Register Notice: FDA will hold a public workshop 9/15 on anti-infective drug development for neonates and young infants. The agency is interested in discussing the scientific challenges pertaining to development of anti-infective products for neonates and young infants. This public workshop is intended to provide information
FDA Policy/General
Federal Register Notice: FDA’s Allergenic Products Advisory Committee will meet 10/27, from 1 p.m. to 4:20 p.m. at FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. The committee will meet by teleconference. In
FDA Policy/General
Federal Register Notice: FDA is requesting that any industry organizations interested in participating in the selecting a nonvoting member to represent the interests of tobacco growers to serve on the Tobacco Products Scientific Advisory Committee, notify FDA in writing. FDA is also requesting nominations for a nonvoting member to represent
FDA Policy/General
AstraZeneca has reported disappointing results from a Phase 3 trial (SELECT-1) of its MEK 1/2 inhibitor, selumetinib, in combination with docetaxel chemotherapy as second-line treatment in patients with KRAS mutation-positive locally-advanced or metastatic non-small cell lung cancer. “The results showed that the trial did
FDA Policy/General
BIOLOGICS FDA Confirms Date for Updated Biological Standards Federal Register Direct final rule: FDA is confirming the effective date of 9/16 for the 5/4 final rule that amends the general biological products standards relating to dating periods and removes certain standards relating to standard preparations and limits of
FDA Policy/General
Federal Register Notice: FDA is issuing a revised draft guidance for industry entitled Dietary Supplements: New Dietary Ingredient Notifications and Related Issues. It supersedes a 7/2011 draft guidance on the same topic. The revised draft guidance, when finalized, will help industry in evaluating whether to submit a premarket safety
FDA Policy/General
Federal Register Notice: FDA is extending the comment period until 9/12 for the document entitled “Infectious Disease Next Generation Sequencing Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers; Draft Guidance for Industry and Food and Drug Administration Staff,” that appeared in the 5/13
FDA Policy/General
Federal Register Final rule: FDA is amending its regulations to correct an error in the lists of statutory and regulatory provisions that provide an opportunity for an informal hearing in connection with a ban of a device. In the list of statutory provisions at Sec. 16.1(b)(1), the
FDA Policy/General
Federal Register Final rule: FDA is making technical corrections to its regulations for hearing procedures for denial of approval or withdrawal of approval of new animal drug applications. FDA is revising Sec. 514.200 to make its language and terminology consistent with the language and terminology of the procedural regulations
FDA Policy/General
Federal Register Notice: FDA is publishing a list of information collections that have been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995 including information on dispute resolutions, SPF labeling, and generic drug user fee cover sheets. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee will meet 10/5 from 8 a.m. to 5 p.m. at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
FDA Policy/General
A study focused on medical device company representatives in surgical suites says there are “ethical questions about the reliance of surgeons on device reps and device companies for education and surgical assistance and practical concerns regarding existing levels of competence among OR personnel.” The research was reported in the open-
FDA Policy/General
The U.S. Court of Appeals for the Ninth Circuit may be re-evaluating how it reviews summary judgments in Freedom of Information Act (FOIA) cases. An 8/3 notice granted an en banc hearing in Animal Legal Defense Fund vs. FDA, but provided no explanation why it was rehearing