Drugs
Former FDA commissioner Robert Califf says there are five things the Trump administration should be aware of if they try to speed drug approvals and reduce FDA regulations. Interviewed by Kaiser Health News, Califf said first that faster drug approvals don’t necessarily mean less expensive drugs. “What I’m
Drugs
CDER has issued a Manual of Policies and Procedures (MAPP) on good review management principles and practices for effective IND development and review. The MAPP is to assist Center review staff on good review management principles and practices for submissions during the IND phase of drug development, promote excellence in
Devices
FDA has cleared a Centric Medical 510(k) for the Metatarsal Hemi Implant System, intended for treating patients with degenerative and post-traumatic arthritis in the metatarsal joint where there is good bone stock along with the following clinical conditions: hallux valgus or hallux rigidus, and an unstable or painful
Drugs
FDA has approved class labeling revisions about the risk of hepatitis B virus (HBV) in patients coinfected with hepatitis C virus (HCV) and hepatitis B virus. An agency notice says the labeling changes include: * test all patients for evidence of current or prior HBV infection before starting treatment with HCV
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
Biologics
FDA has accepted for review a CSL Behring clinical efficacy supplement on its BLA for to Privigen [immune globulin intravenous (human), 10% liquid], its intravenous immunoglobulin. The supplement seeks to obtain approval for a new indication — treatment of chronic inflammatory demyelinating polyneuropathy (CIDP), a rare and progressing disease that may
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
Drugs
A False Claims Act settlement last month (see earlier story) by Baxter Healthcare is being characterized as unusual because it was not an off-label promotion or kickback activity-related action typically seen in such settlements. “Instead the Baxter case was based on an allegation that Baxter manufactured products in
Drugs
Zosano Pharma says it is planning an NDA for its migraine drug M207 after reporting clinical trial (ZOTRIP) results where both co-primary endpoints of pain freedom and most bothersome symptom freedom at two hours were met. The placebo-controlled, dose-ranging trial compared three transdermal doses (1.0mg, 1.
Drugs
FDA has partially approved an Alcon citizen petition that asked the agency to require only in vivo bioequivalence testing for ANDAs that cite its Ciprodex (ciprofloxacin 0.3% and dexamethasone 0.1%) sterile otic suspension as the reference-listed drug. The petition said that a recently revised FDA draft guidance
Drugs
FDA has approved an updated label for Eli Lilly’s once-weekly Trulicity (dulaglutide) to include use in combination with basal insulin for adults with Type 2 diabetes. Trulicity is a once-weekly glucagon-like peptide-1 receptor agonist injectable prescription medicine designed to improve blood sugar (glucose) in adults
Drugs
Washington Legal Foundation has asked the U.S. Supreme Court to review and ultimately overturn a divided Eighth Circuit ruling that upheld a term of imprisonment for two executives of Quality Egg LLC under the “responsible corporate officer” (RCO) doctrine. In a brief filed in DeCoster v. United States, WLF
Devices
Aeterna Zentaris says it is planning to seek FDA approval for Macrilen (macimorelin) for evaluating growth hormone deficiency in adults. A recent Phase 3 confirmatory study entitled Confirmatory validation of oral macimorelin as a growth hormone stimulation test for the diagnosis of adult growth hormone deficiency in comparison with the
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
Devices
Zimmer Biomet has begun a Class 1 recall of its Comprehensive Reverse Shoulder System Humeral Tray due to a higher than anticipated rate of fracturing that is design related. Such fracturing increases the risk of revision surgery, an FDA notice says. The company is asking that hospitals Immediately return all
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
Drugs
Based on positive data, Janssen Research & Development says it has stopped early a Phase 3 trial (COMPASS) that was evaluating the efficacy and safety of Xarelto (rivaroxaban) for preventing major adverse cardiac events (MACE), including cardiovascular death, myocardial infarction and stroke in patients with coronary artery disease or with
Devices
FDA deputy director for personalized medicine Elizabeth Mansfield is leaving the agency next week to join cancer screening start-up Grail Inc. as its head of regulatory strategy. Mansfield had been at FDA for 10 years. Grail is a spin-off from Illumina, which makes most of the DNA sequencing
Drugs
FDA has cleared a Biolase 510(k) for its fifth-generation Waterlase Express all-tissue laser system for use in dental procedures. The device features step-by-step, 4K high-definition animations for every step of a procedure. Its procedures are organized into clinical categories, and it allows user to
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
Drugs
Sen. Chuck Grassley (R-IA) says he is gathering information on possible misuses of the orphan drug program and how that might affect drug prices. “Based on the reporting from Kaiser Health News about how the orphan drug provisions appear to be stretched beyond their original intent, and the strong