Drugs
FDA has approved a Flexion Therapeutics NDA for Zilretta (triamcinolone acetonide extended-release injectable suspension), an extended-release, intra-articular injection for osteoarthritis knee pain. The product is designed with Flexion’s proprietary microsphere technology to provide pain relief over 12 weeks, according to the company. Approval is based on
Devices
Senators Elizabeth Warren (D-MA) and Chuck Grassley (R-IA) are urging that medical device identifier information be added to Medicare claims in order to better track faulty devices. The senators’ concern arises from a HHS Office of Inspector General (OIG) report earlier this week that was critical of Medicare
Drugs
FDA has approved a Flexion Therapeutics NDA for Zilretta (triamcinolone acetonide extended-release injectable suspension), an extended-release, intra-articular injection for osteoarthritis knee pain. The product is designed with Flexion’s proprietary microsphere technology to provide pain relief over 12 weeks, according to the company. Approval is based on
Drugs
Federal Register notice: FDA has determined that the regulatory review period for patent restoration purposes for Biogen Idec’s Tecfidera (dimethyl fumarate) is 2,480 days — of this, 2,085 days occurred during the testing phase and 395 days occurred during the approval phase. To view the notice, click here.
Drugs
Baxter International has recalled one shipment from a single lot of Intralipid 20% IV Fat Emulsion, 100 mL, distributed between 8/11 and 8/31 to hospitals and healthcare providers in the U.S. The product was exposed to subfreezing temperatures during transit to a distribution facility, a recall notice
Drugs
CDER has published a new Manual of Policies and Procedures (MAPP 5200.12) on “Communicating Abbreviated New Drug Application Review Status Updates with Industry.” The document clarifies general principles and procedures for communicating an ANDA review status update with sponsors. The policy is mandated under the Generic Drug User Fee
Drugs
FDA has awarded 15 new clinical trial research grants totaling more than $22 million over the next four years to advance product development for patients with rare diseases. “For more than 30 years, the FDA has been committed to investing in trials of potentially life-changing treatments for patients with
FDA Policy/General
FDA continues working with Puerto Rico-based manufacturing facilities to restore their capacity in order to prevent possible medical product shortages, according to an update by commissioner Scott Gottlieb. “These facilities are a key component of the island’s economic vigor,” he said. “The pharmaceutical and biological drug products and
FDA Policy/General
Federal Register notice: FDA has determined that the regulatory review period for patent extension purposes for Abiomed Europe’s Impella 2.5 System is 3,227 days — of this, 2,858 days occurred during the testing phase and 369 days occurred during the approval phase. To view the notice, click
Biologics
There were 669 total CBER recall events by class in FY 2017, up 11% from 575 in FY 2016. There were 427 Class 2 recalls spread over nine categories and 185 Class 3 recalls, as well as 57 mixed class (2 and 3) recalls, according to the FY 2017 report.
Drugs
The American Civil Liberties Union has filed suit in Hawaii federal court challenging the FDA REMS (Risk Evaluation Mitigation Strategy) for the Mifeprex abortion pill. The suit, filed on behalf of a Hawaii doctor and several professional healthcare associations says the REMS restricts where a woman may receive Mifeprex, which
Drugs
A Massachusetts federal court has ruled that a potential class action suit against manufacturers of prescription eye drops could not proceed because of impossibility preemption. Plaintiffs claimed that the manufacturers used eye drop dispensers that were “intentionally designed to dispense more liquid than the human eye is capable of absorbing.
Drugs
FDA Office of Minority Health director Jonca Bull has left FDA to join Pharmaceutical Product Development in a dual role as head of regulatory consulting and as vice president of ophthalmology within global product development. Prior to her FDA post, Bull (XXX DELETE XX)served as vice president for U.
Drugs
The Justice Department says the owner of a Decatur, AL, compounding pharmacy has been charged with conspiracy to defraud the Defense Department Tricare healthcare program out of more than $10 million. Federal prosecutors charged John Lemley and are seeking to have him forfeit nearly $1 million as proceeds of the
FDA Policy/General
Federal Register notice: FDA has announced a 10/19 regional public meeting entitled “Health Canada and U.S. Food and Drug Administration Joint Public Consultation on International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).” The meeting is intended to provide information and solicit public input
FDA Policy/General
Federal Register notice: FDA has announced an 11/6-7 Science Advisory Board to the National Center for Toxicological Research meeting. On 11/6, an update will be provided on scientific initiatives and accomplishments during the past year. On 11/7, FDA medical product centers will each briefly discuss their
Devices
The Supreme Court will decide this term whether to review a product liability lawsuit that raises the question of whether a medical device manufacturer may introduce evidence related to FDA premarket review and clearance of a medical device in a case in which a consumer alleges that the device is
Drugs
FDA says industry can now request pre-ANDA meetings for complex generic drug products through CDER’s Direct NextGen Collaboration Portal. An online post on the portal says the pre-ANDA program is a valuable information resource for generic drug applicants that features product development assistance and pre-submission and
Drugs
FDA has approved a McGuff Pharmaceuticals NDA for Ascor (ascorbic acid injection USP), a vitamin C drug product for the short term (up to one week) treatment of scurvy in adult and pediatric patients aged five months and older for whom oral administration is not possible, insufficient or contraindicated. The
Devices
FDA has approved a Roche Molecular Systems PMA for the cobas Zika test, a qualitative nucleic acid test for detectimg Zika virus RNA in individual plasma specimens obtained from volunteer donors of whole blood and blood components, and from living organ donors. “The test’s clinical specificity was evaluated by
Drugs
The HHS Inspector General (OIG) says that generally FDA has spent prescription drug user fee collections appropriately. An OIG audit report says it looked at $796,065,980 in prescription drug user fees reported for 10/1/14 through 9/30/15. The report says that while FDA generally spent
Devices
FDA has cleared a Nexxt Spine 510(k) for the Nexxt Matrixx System, 3-D printed porous titanium equipment for creating interbody and vertebral body replacement (VBR) devices. The 3-D system features “optimized open architectural porosity, residue-free surface technology, and robust radiographic imaging performance,” according to the company.