Drugs
Shire has submitted an NDA for a chewable tablet formulation of Vyvanse (lisdexamfetamine dimesylate) for treating attention-deficit/hyperactivity disorder patients who may have difficulty swallowing or opening a capsule. The submission is based on data from two clinical pharmacology studies that demonstrated the chewable tablet formulation is bioequivalent to
Devices
FDA has cleared an EOS Imaging 510(k) for spineEOS, an online 3D planning software for spine surgery based on the company’s EOS stereo-radiographic 2D/3D imaging technology. The planning software is intended for adults suffering from degenerative or deformative spine conditions, as well as for pediatric patients
Devices
Sen. Al Franken (D-MN) is asking FDA for answers to questions about its role in maintaining vigilance over medical devices. Franken’s questions in a 4/12 letter to FDA commissioner Robert Califf stem from a Minneapolis Star Tribune article detailing issues with Medtronic’s Infuse bone graft device
Devices
An Internet petition to Congress authored by LASIK injured patient/activist and former CDRH advisory committee consumer representative Paula Cofer has drawn more than 270 signatures from across the country in its first 24 hours, demanding the removal of CDRH director Jeffrey Shuren from office. Last October, Cofer and some
Drugs
Members of the FDA Nonprescription Drugs Advisory Committee will be asked 4/15 to comment on a Galderma sNDA for a full prescription to OTC switch for its acne drug Differin (adapelene gel 0.1%) as a once daily topical application. A staff briefing document released in advance of the
Drugs
Merck says that the C-EDGE comparative Phase 3 study of Zepatier (elbasvir and grazoprevir) versus a regimen of Gilead’s Sovaldi (sofosbuvir) plus peginterferon and ribavirin showed Zepatier superiority in treatment-experienced patients with chronic hepatitis C genotype 1 or 4 infection. FDA approved the drug 1/28 based
Drugs
FDA has issued a draft guidance, Data Integrity and Compliance with CGMP, to clarify the role of data integrity in current good manufacturing practice for drugs. The document says that the agency expects that data will be reliable and accurate. CGMP regulations and guidance allow for flexible and risk-based
Drugs
FDA has posted the results of five drug safety evaluations completed between 10/1 and 12/31/15. For four of the five — Wyeth’s Duavee (conjugated estrogens/bazedoxifene) tablet, film-coated; Medicis’ Luzu (luliconazole) cream; zoledronic acid injection; and Iroko’s Zorvolex (diclofenac) capsule — no new safety issues were
Drugs
Researchers say that doctors often don’t understand the meaning of FDA approval of a drug. A report in the Journal of the American Medical Association says the researchers surveyed board-certified internists and specialists and found “substantial deficits in knowledge of the meaning of FDA approval. Physicians tended to
Devices
FDA has approved an Epigenomics PMA for its Epi proColon, the first FDA-approved blood-based colorectal cancer screening test. The device is indicated for colorectal cancer screening in average-risk patients who choose not to undergo colorectal cancer screening by guideline-recommended methods such as colonoscopy and stool-based
Devices
FDA has cleared an EOS Imaging 510(k) for spineEOS, an online 3D planning software for spine surgery based on the company’s EOS stereo-radiographic 2D/3D imaging technology. The planning software is intended for adults suffering from degenerative or deformative spine conditions, as well as for pediatric patients
Drugs
CDER Office of Generic Drugs (OGD) director Kathleen Uhl says that the office is on track to meet the goals set for it under the 2012 Generic Drug User Fee Act (GDUFA). Writing in an FDA Voice blog post, Uhl says that 2015 was the first full year of operation
Drugs
FDA has accepted for review a Pain Therapeutics NDA resubmission for Remoxy (oxycodone) extended-release capsules in an abuse-deterrent formulation for treating pain. The agency has set a user fee review target date of 9/25. The submission was made despite Pfizer deciding in 2014 to discontinue its agreement
Devices
A Nevada federal court has held that PMA preemption extends beyond medical devices approved through the traditional PMA process to include those approved under a humanitarian device exemption (HDE). Attorney John Sullivan (Cozen O’Connor) writes in an online blog post that the case involved an implanted device intended to
Drugs
FDA has accepted for review an sBLA for Merck’s Keytruda (pembrolizumab) for treating patients with recurrent or metastatic head and neck squamous cell carcinoma with disease progression on or after platinum-containing chemotherapy. Merck says that its application seeks approval for Keytruda as a single agent at a dose
FDA Policy/General
Former CDER Office of Compliance director Cynthia Schnedar has joined consulting firm Greenleaf Health as the group’s new regulatory compliance executive vice president. Schnedar resigned earlier this month, with her departure coming three months after she was recused from working on substantive issues relating to compliance actions and policy
Devices
FDA says that Focus Diagnostics has recalled specific lots of its laboratory examination kits supplied with Simplexa herpes simplex virus 1 & 2 and Simplexa Group A strep direct amplification discs. The agency notice says that the kits were manufactured between 7/30/15 and 2/11/16, and were
FDA Policy/General
Federal Register Notice: FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee will meet 5/24, from 8 a.m. to 6 p.m. at the Hilton Washington DC North/Gaithersburg, Salons A, B, C and D, 620 Perry Pkwy., Gaithersburg, MD. The committee will discuss, make
Drugs
An 8/17-8/21/15 FDA inspection at the Pikeville Medical Center Institutional Review Board (IRB) Pikeville, KY, found that the IRB did not adhere to applicable FDA regulations governing the protection of human subjects. A just-released 3/1 Warning Letter says that violations shown on an FDA-
Drugs
CDER Office of Pharmaceutical Quality deputy director Lawrence Yu says that while it is not easy for drug manufacturers to transition from batch to continuous manufacturing, there are significant rewards and FDA is encouraging companies to consider making the effort. Writing in an FDA Voice blog post, Yu says that
FDA Policy/General
FDA has cleared an Oculus Innovative Sciences 510(k) for the Microcyn-based Lasercyn Gel, intended for use for managing post-non-ablative laser therapy procedures, post-microdermabrasion therapy and following superficial chemical peels. Lasercyn may also be used to relieve itch and pain from minor skin irritations, lacerations, abrasions
FDA Policy/General
FDA has cleared an Oculus Innovative Sciences 510(k) for the Microcyn-based Lasercyn Gel, intended for use for managing post-non-ablative laser therapy procedures, post-microdermabrasion therapy and following superficial chemical peels. Lasercyn may also be used to relieve itch and pain from minor skin irritations, lacerations, abrasions