FDA Policy/General
Federal Register notice: FDA has classified the cervical intraepithelial neoplasia (CIN) test system into Class 2 (special controls). The action responds to a 5/2016 de novo classification request from Ventana Medical Systems for its CINtec Histology device. The device is used to detect a biomarker associated with CIN in
Devices
FDA has cleared a Cerebrotech Medical Systems 510(k) for the Cerebrotech Visor, previously known as the CMS-5000 Intracranial Fluids Monitor. The clearance includes a broad indication for use as an aid in assessing fluid volume differences between the cerebral hemispheres in patients undergoing neurologic assessment. The company says
FDA Policy/General
A Health Affairs year-in-review says that one of the biggest drug policy stories in 2017 was the bipartisan cooperation that led to passage of the FDA Reauthorization Act of 2017 that continued the FDA user fee program. The review also says that FDA commissioner Scott Gottlieb has established
Drugs
FDA has cleared a Cerebrotech Medical Systems 510(k) for the Cerebrotech Visor, previously known as the CMS-5000 Intracranial Fluids Monitor. The clearance includes a broad indication for use as an aid in assessing fluid volume differences between the cerebral hemispheres in patients undergoing neurologic assessment. The company says
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance on “Labeling for Combined Hormonal Contraceptives.” The document provides recommendations on information that should be included in the prescribing information for combined hormonal contraceptives, which contain estrogen and progestin. Such products include combined oral contraceptives, as well as non-oral
FDA Policy/General
Federal Register notice: FDA has announced a 3/23 Pediatric Advisory Committee meeting. Panel members are scheduled to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act of 2003. To view the notice, click here.
FDA Policy/General
Some 60 groups representing patients, healthcare providers, public health experts, women, people of color, workers, consumers, and people of faith are telling senators that it would be detrimental to Americans for Alex Azar to be named HHS secretary. A 1/3 letter to senators (link in Public Citizen statement) says
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Establishing Effectiveness for Drugs Intended to Treat Male Hypogonadotropic Hypogonadism Attributed to Non-Structural Disorders.” The document provides key design considerations, including recommendations for patient enrollment criteria and efficacy endpoints, for clinical trials to establish effectiveness for such drugs.
Devices
FDA has cleared a Zimmer Biomet Holdings 510(k) for the Sidus Stem-Free Shoulder system as a total shoulder arthroplasty solution for patients with good bone stock who have either osteoarthritis, post-traumatic arthrosis, focal avascular necrosis of the humeral head or who had previous surgeries of the shoulder
Drugs
FDA has denied an 8/2017 Allergan petition asking it to refuse to approve any pending ANDA for cyclosporine ophthalmic emulsion for which its Restasis is the reference-listed drug that relies on in vitro or other non-clinical analyses, and does not rely on one or more appropriately designed
Drugs
FDA commissioner Scott Gottlieb says the agency has issued a draft guidance and a Manual of Policies and Procedures (MAPP) intended to help improve the efficiency and predictability of the agency’s generic drug review process to reduce the time it takes to get a new generic drug approved and
Drugs
A new HHS Office of Inspector General report found that from 2012 to 2016 Medicaid may have lost $1.3 billion in base and inflation-adjusted rebates for 10 potentially-misclassified drugs with the highest total reimbursement in 2016. “The vast majority of the approximately 30,000 drugs in the
FDA Policy/General
Clinical trial data integrator Datavant has appointed former FDA chief information officer Eric Perakslis as its chief scientific officer. Based in San Francisco, Datavant’s products are designed to improve the design and interpretation of clinical trials through data integration and artificial intelligence, “increasing the odds of success of clinical
Drugs
PharMEDium Services has recalled several lots of drug products to the hospital/user level due to a lack of sterility assurance. “PharMEDium conducted a retrospective review of all commercially distributed product lots compounded in the Memphis location currently within their labeled expiration date in response to an FDA request regarding
FDA Policy/General
Federal Register notice: FDA has announced a joint Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee meeting 2/14. The committees will discuss a Charleston Laboratories NDA for Hydexor, a fixed-dose combination oral tablet containing hydrocodone, acetaminophen, and promethazine, for the short-
FDA Policy/General
Federal Register notice: FDA has issued a priority review voucher to Spark Therapeutics for gaining BLA approval of Luxturna (voretigene neparvovec), an adeno-associated virus vector-based gene therapy indicated for the treatment of patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy. The agency awards priority review vouchers to
Drugs
FDA has released the FDA-483 issued following a 10/16-10/23/17 inspection at KRS Global Biotechnology, Boca Raton, FL, an outsourcing facility. The observations were: * equipment used in the manufacture, processing, packing, or holding of drug products is not of appropriate design to facilitate operations for its
Drugs
FDA has published online instructions for NDA and ANDA holders to use in submitting a one-time marketing status report required by the FDA Reauthorization Act of 2017. NDA and ANDA holders are to review information published in the Orange Book and submit a one-time report indicating that (1)
Drugs
An Illinois federal judge has overturned a $150 million verdict against AbbVie in a case that alleged the company fraudulently misrepresented the risks of its AndroGel testosterone replacement drug. According to Reuters, the judge found that the findings by a jury that rendered its verdict 7/2017 were “logically incompatible.
Drugs
FDA says it is seeking nominations to join the agency’s Patient Engagement Collaborative (PEC). An FDA Voice blog post says the PEC is looking for: * patients who have personal disease experience; * caregivers who support patients, such as a parent, child, partner, other family member, or friend, and who have
FDA Policy/General
The following are summaries of the Federal Register notices published during FDA Webview’s holiday break: ANIMAL DRUGS Federal Register final rule: FDA has issued a final rule that amends the regulations for new animal drugs for investigational use to expand the scope of clinical investigator disqualification to include ineligibility
FDA Policy/General
Here are the FDA Warning Letters that were released during the FDA Webview’s holiday break at the end of December: AN Co. Ltd. Gyeonggi-do, Korea (12/13/2017): FDA inspected the firm 5/2017 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to