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FDA commissioner Scott Gottlieb says the agency has issued a draft guidance and a Manual of Policies and Procedures (MAPP) intended to help improve the efficiency and predictability of the agency’s generic drug review process to reduce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
Drugs
FDA has approved Spark Therapeutics’ Luxturna (voretigene neparvovec-rzyl), a new gene therapy to treat children and adults with an inherited form of vision loss that may result in blindness. An agency news release says that Luxturna is the first directly administered gene therapy approved in the U.S. that
Drugs
FDA says it will take a new risk-based enforcement approach to drug products labeled as homeopathic. “To protect consumers who choose to use homeopathic products,” an agency news release says, “this proposed new approach would update FDA’s existing policy to better address situations where homeopathic treatments are being
Drugs
Sens. Chuck Grassley (R-IA) and Amy Klobuchar (D-MN) are asking FDA commissioner Scott Gottlieb whether the agency’s enforcement policies on prescription drugs imported from Canada has changed. The senators’ 12/21/17 letter follows an 11/20/17 Kaiser Health News report that FDA sent Office of
Devices
FDA has given 510(k) clearance to Xcision Medical Systems’ GammaPod stereotactic radiotherapy system intended to treat cancer in breast tissue. An agency news release notes that some 60% of all cancer patients are treated with some form of radiation therapy. The GammaPod system is intended for use in the
Devices
FDA is permitting marketing of Sanuwave’s Dermapace System, described by the agency as the first shock wave device intended to treat diabetic foot ulcers. An agency news release says the system is intended to be used to treat chronic, full-thickness diabetic foot ulcers with wound areas measuring no
Drugs
CDER innovative drug approvals sharply rebounded in 2017 — more than doubling the 22 products approved in 2016, which was a significant down year for approvals. In all, the Center approved 46 innovative NDA/BLAs last year. In contrast, there were just 22 approved in 2016 and 45 in 2015, according
Drugs
FDA has published a final guidance and a draft guidance addressing communications between the agency and drug sponsors. The final guidance, Best Practices for Communication Between IND Sponsors and FDA During Drug Development, describes best practices and procedures for timely, transparent, and effective communication between IND sponsors and FDA at
Drugs
Washington Legal Foundation (WLF) says that a 3rd Circuit Court of Appeals decision in a patent reverse payment case involving Pfizer and Ranbxy “represents a major expansion of antitrust law” and directly conflicts with the Supreme Court’s Actavis decision. In a brief asking the high court to hear Pfizer’