Drugs
A just-filed citizen petition has asked FDA to determine whether the 180-day marketing exclusivity for a Handa ANDA for quetiapine fumerate extended-release tablets has effectively been forfeited for failing to obtain tentative approval within 30 months. It also asks the agency to determine whether Handa is not
Drugs
HHS has issued further guidance on how FDA can meet exemptions for hiring critical employees to fulfill its mission and meet requirements under the law. A department memo provides a list of FDA-related positions — such as consumer safety officer, medical officer, pharmacologist, chemists, engineers, etc. — that are exempt from
Devices
FDA says it has received multiple reports of two different types of adverse events associated with fluid-filled intragastric balloons used to treat obesity. An alert to healthcare providers says the first type of adverse event involves the balloon over-inflating with air or with more fluid in patients’ stomachs,
Devices
The Federal Trade Commission (FTC) has approved a final order settling charges that Valeant Pharmaceuticals International, the parent company of Bausch & Lomb, illegally acquired Paragon Holdings, a producer of polymer discs used in making rigid gas permeable contact lenses. The commission alleged that Valeant’s 2015 acquisition of Paragon
Drugs
A California federal court has approved a consent decree sought by FDA with dietary supplement distributor Regeneca Worldwide, requiring it to stop selling its products, which were found to contain unsafe ingredients, including 1,3-dimethylamylamine (DMAA). An FDA news release says that DMAA is an amphetamine derivative that has
Drugs
FDA has cleared an Access Scientific 510(k) for its new 3 French, 6cm Powerwand, an extended-dwell intravenous (IV) catheter designed for forearm and upper-arm (midline) placement to eliminate the repetitive needlesticks experienced by many hospitalized patients. The device is made of proprietary Chronoflex C, and is longer
Drugs
Exela Pharma Sciences, in association with marketer X-Gen Pharmaceuticals, has recalled one lot (PLND1613) of ibuprofen lysine injection, 20mg/2mL (10mg/mL) because some vials have been found to contain particulate matter. “Particulate matter has the potential to block blood vessels, provoke an immune reaction, and/or lead to
Drugs
Acorda Therapeutics says it will file an NDA next quarter for Parkinson’s therapy CVT-301 after reporting Phase 3 clinical data that showed a statistically significant improvement in motor function in people with Parkinson’s disease experiencing motor fluctuations (OFF periods). CVT-301 is an investigational, inhalable formulation of
Drugs
FDA and Armetheon have reached agreement for a single 1,000-patient final pivotal trial for its drug candidate, tecarfarin (Tecarfarin for AntiCoagulation Trial or TACT) prior to filing an NDA, which is expected in 2019. The agency told Armetheon that it can amend an existing Special Protocol Assessment for
Drugs
The Medical Information Working Group, Pharmaceutical Research and Manufacturers of America, and Biotechnology Information Organization have petitioned FDA to indefinitely stay the agency’s 1/9 final rule relating to intended uses of drug, medical devices, and combination products and to reconsider the final rule. The petition says that agency
Drugs
FDA has approved Marathon Pharmaceuticals’ Emflaza (deflazacort) tablets and oral suspension to treat patients age 5 and older with Duchenne muscular dystrophy (DMD). An agency news release says that Emflaza is a corticosteroid that works by decreasing inflammation and reducing immune system activity. Although corticosteroids are commonly used to treat
FDA Policy/General
Politico says that with a vote to confirm Rep. Tom Price as HHS secretary likely this week or next, nomination of an FDA commissioner should not be far behind. The report says that President Donald Trump signaled last week that he has made his choice, reportedly either former FDA deputy
Drugs
FDA says it has updated the Model Bioequivalence Data Summary Tables. The agency says the revisions were minor to accommodate compliance with the requirement to submit standardized study data including deletion of definition tables.
Drugs
CDER has told Portola Pharmaceuticals that as part of its mid-cycle NDA review for betrixaban, there is no intention to hold an advisory committee meeting for the once-daily Factor Xa inhibitor anticoagulant. The NDA is under a priority review for extended-duration prophylaxis of venous thromboembolism (VTE) in
Drugs
Physio-Control has begun a Class 1 recall of Lifepak15 monitor/defibrillator due to the failure of the device to deliver an electrical shock. Electrodes connected to the defibrillator help the device analyze a patient’s heart rhythm and deliver an electrical shock to restore normal heart rhythm when needed.
Biologics
FDA has granted Angionetics a Fast Track designation for Generx [Ad5FGF-4], a cardiovascular angiogenic gene therapy for use as a one-time treatment for improving exercise tolerance in patients who have angina that is refractory to standard medical therapy and not amenable to conventional revascularization procedures (coronary artery bypass
Devices
The Government Accountability Office (GAO) has completed a long-awaited report that confirms serious gaps in FDA’s medical device reporting process that failed to identify adverse events associated with power morcellators used in removing uterine fibroids. Power morcellators had been on the market for more than two decades before
Drugs
Public Citizen has petitioned FDA to immediately remove from the market hydroxethyl starch (HES) solutions that have been marketed since 1972 as an option for treating patients who need IV solutions to maintain or increase their fluid volume. The petition says HES solutions should be removed from the market because
Drugs
The National Center for Policy Analysis (NCPA), which describes itself as a nonprofit, nonpartisan public policy research organization, says that “to a significant degree, over-priced drugs are a problem exacerbated by the regulatory regime at FDA, coupled with a lack of guidance from Congress.” In an issue brief, the
FDA Policy/General
Public Citizen, the Natural Resources Defense Council, and the Communication Workers of America have filed a complaint in DC federal court seeking an injunction to stop implementation of President Donald Trump’s executive order on reducing regulations and controlling regulation costs. The complaint names Trump, the acting director of the
Drugs
FDA has issued a guidance, Dear Healthcare Provider Letters: Improving Communication of Important Safety Information, to give industry recommendations on the content and format of Dear Healthcare Provider letters. Such letters, the document says, are intended to alert doctors and other healthcare providers about important new or updated information regarding
FDA Policy/General
Sen. Chuck Grassley(R-IA) is calling on President Donald Trump to stage a Rose Garden ceremony at the White House to honor whistleblowers. In a 2/8 letter, Grassley says that whistleblowers have been trying to “drain the swamp” in Washington since the nation’s founding. “Whistleblowers are brave,