Drugs
FDA has accepted an Allergan NDA for ulipristal acetate, an investigational drug for treating abnormal uterine bleeding in women with uterine fibroids. Ulipristal acetate is a selective progesterone receptor modulator that acts directly on the progesterone receptors in three target tissues: the endometrium (uterine lining), uterine fibroids, and the pituitary
Drugs
FDA medical reviewers are posing tough questions for members of the Cellular, Tissue, and Gene Therapies Advisory Committee when they meet 10/12 to consider a BLA submitted by Spark Therapeutics for Luxturna (voretigene neparvovec) for treating patients with vision loss due to confirmed biallelic RPE65 mutation-associated retinal dystrophy.
Drugs
In its fourth major decision since May for drug products aimed at non-small cell lung cancer (NSCLC), FDA has accepted for priority review a Boehringer Ingelheim supplemental NDA for Gilotrif (afatinib) that seeks an indication for first-line treatment of certain patients with metastatic NSCLC whose tumors have epidermal
Drugs
FDA has approved a Respicardia PMA for the Remed System as a treatment option for patients who have been diagnosed with moderate to severe central sleep apnea. The implantable device stimulates a nerve located in the chest that is responsible for sending signals to the diaphragm to stimulate breathing, according
Drugs
FDA has cleared a Roche 510(k) for the Cobas C-diff Nucleic acid test for detecting the toxin B (tcdB) gene of toxigenic Clostridium difficile. The automated qualitative in vitro diagnostic test uses real-time polymerase chain reaction to detect the tcdB gene in soft or liquid stool specimens
Drugs
FDA has accepted an Amgen supplemental BLA for Prolia (denosumab) for treating patients with glucocorticoid-induced osteoporosis. The agency has set a user fee review action target date of 5/28/2018. The submission is based on a Phase 3 study evaluating Prolia compared with risedronate in patients receiving glucocorticoid
Drugs
FDA has granted AstraZeneca a breakthrough therapy designation for Tagrisso (osimertinib) for the first-line treatment of patients with metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC). The designation was based on data from the Phase 3 FLAURA trial of Tagrisso versus standard-of-
Drugs
FDA has awarded six new research grants ($6.3 million) for natural history studies in rare diseases that are intended to evaluate how they progress over time. “One potential application of these studies is the opportunity to eventually use natural history models to augment the need for placebo arms in
Drugs
FDA has cleared a Game Ready 510(k) for its orthopedic rehabilitation device, the Med4 Elite. The device is controlled by an intuitive touchscreen computer interface to deliver iceless cold therapy, heat therapy, rapid contrast (alternating heat and cold) therapy and intermittent pneumatic compression therapy, the company says. It is
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
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
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
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
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