FDA Policy/General
DEVICES 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
FDA Policy/General
Draft Guide on Drug Starting Materials Federal Register Notice: FDA has made available a draft guidance entitled “Q11 Development and Manufacture of Drug Substances — Questions and Answers (regarding the selection and justification of starting materials).” The International Council for Harmonization guidance is intended to clarify the principles for selecting starting
FDA Policy/General
Federal Register Notice: FDA has issued an order to permanently debar Raymond Sean Brown from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Dr. Brown was convicted of a felony under federal law
FDA Policy/General
The Government Accountability Office (GAO) continues to monitor FDA staff vacancies at foreign agency posts as part of its identification of high-risk areas needing improvement. A new GAO report notes that as of 7/2016, 46% of FDA foreign offices’ authorized positions, including those conducting medical product investigations, were
FDA Policy/General
Federal Register Notice: FDA has issued an order debarring Karis Copper Delong for a period of 12 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Ms. Delong was convicted of four
FDA Policy/General
Federal Register Notice: FDA’s Cincinnati District is co-sponsoring with Xavier University a public conference 3/15-17 entitled ‘“FDA/Xavier University PharmaLink Conference: Leadership in a Global Supply Chain.” Topics to be discussed include How Big Data and Artificial Intelligence Can Enhance Your Proactive Risk Monitoring Programs; Connecting
FDA Policy/General
FDA announced 2/17 the approval of Maryland Heights, MO-based Anzac Animal Health’s Diroban (melarsomine dihydrochloride), the first generic drug to treat heartworm disease in dogs. An agency news release said the drug is administered by deep injection into the back muscles. It is used to treat dogs
FDA Policy/General
CBER’s Advertising and Promotional Labeling Branch says the presentation slides introducing Fenwal’s InterSol (platelet additive solution 3) Solution are misleading because they present efficacy claims but omit all risk information. A just-released 10/14/16 Warning Letter says the violations are concerning from a public health perspective
FDA Policy/General
Federal Register Notice: FDA has announced an amendment to a 3/6-7 Pediatric Advisory Committee. The meeting was first announced in the 1/5 Federal Register. The amended notice outlines the products that will undergo pediatric-focused safety reviews as mandated by the Best Pharmaceuticals for Children Act — Nitropress
FDA Policy/General
Just-released FDA enforcement statistics shows that recalls in FY 2016 fell 10% compared with recalls tracked in 2015. There were 8,305 product recalls in 2016, almost 900 fewer than the 9,178 recall actions in 2015. FDA Webview reported 2/14 that agency Warning Letters also fell substantially
FDA Policy/General
Federal Register Notice: FDA has released a revised draft guidance on bioequivalence recommendations for generic difluprednate emulsion. The document provides input on the design of bioequivalence studies to support ANDAs for difluprednate emulsion. To view the guidance, click here. To view the notice, click here.
FDA Policy/General
The Office of Management and Budget (OMB) is likely to get many questions on the Trump administration’s executive order on reducing regulations, according to attorneys Laurence Platt and Joy Tsai (both Mayer-Brown). Writing in an online legal update, the two say that while many people may see a
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Ausmetics Daily Chemicals (Guangzhou) Co. Guangdong, China (1/31): FDA inspected the firm 7/2016 and cited significant GMP violations related to finished pharmaceuticals. For example, the firm failed
FDA Policy/General
Sen. Bill Nelson (D-FL) has introduced a bill that aims to protect “scientific integrity” in federal research and policymaking. The bill, which has been referred to the Committee on Commerce, Science and Transportation, seeks to protect science and its findings from political and ideological influence. It is intended to
FDA Policy/General
Ipsen has entered into a definitive agreement to acquire from Sanofi for $88 million five consumer healthcare products in certain European territories. The most significant product is Prontalgine, an analgesic for treating moderate to severe pain. The portfolio also includes Buscopan, an antispasmodic; Suppositoria Glycerini, a laxative; and Mucothiol and
FDA Policy/General
FDA GENERAL Comments Sought on Advisory Panel New Member Nominations Federal Register Notice: FDA is seeking comments on a new information collection under its “Process for Collecting Nominations of Candidates to Serve on FDA’s Advisory Committees.” In order to identify and select qualified individuals to serve on its advisory
FDA Policy/General
Rep. Tom Price (R-GA) was sworn in 2/10 as HHS secretary after being confirmed overnight (52 to 47) following a series of grueling Senate hearings. During the hearings, Price came under fire for alleged conflicts of interest (see earlier story) related to stock purchases. Presumably, Price’s nomination
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
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
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,
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Berkeley Nutritional Manufacturing Corp. Livermore, CA (1/31): FDA inspected the firm 2/2016 and documented serious GMP violations for dietary supplement products. FDA also found labeling violations for
FDA Policy/General
Reps. Fred Upton (R-MI) and Diana DeGette (D-CO) have written the White House Office of Management and Budget asking for additional guidance clarifying whether FDA is exempt from a hiring freeze ordered last month. The lawmakers, who played instrumental roles in drafting the 21st Century Cures law, are