Drugs
A Georgia federal judge found fault with several FDA arguments but still determined that Hi-Tech Pharmaceuticals’ DMAA (1,3-dimethylamylamine) is not a dietary ingredient. An online blog post says the agency has been trying for years to remove the ingredient from the dietary supplement market. The court’s
Drugs
A Philadelphia Court of Common Pleas judge has dismissed a suit against Cephalon claiming that it promoted an opioid medication off-label. Attorney Michelle Yeary (Dechert) says the plaintiff claimed that he became addicted to the opioid cancer pain drug that he was given to treat his migraines. Yeary says
FDA Policy/General
Federal Register Notice: FDA has announced a 4/12 public workshop on new developments and scientific issues related to antibody mediated rejection (AMR) in kidney transplantation. The workshop is intended to provide information on various aspects of clinical development of medical products for prophylaxis and treatment of AMR in kidney
FDA Policy/General
Federal Register Notice: FDA is co-sponsoring with Xavier University a public conference entitled “FDA/Xavier University Medical Device Conference.” The 5/3-5 conference will be held on the campus of Xavier University in Cincinnati, OH, and will cover generic regulatory issues involving medical device regulation. To view the
FDA Policy/General
Federal Register Notice: FDA has determined that Pernix Therapeutics’ antibiotic Cedax (ceftibuten dihydrate) for oral suspension, 90 milligrams (mg)/5 milliliters (mL) and 180 mg/5 mL, were not withdrawn for reasons involving safety or effectiveness. This determination will allow the agency to approve ANDAs for ceftibuten dihydrate for oral
Drugs
Medtronic has issued a field corrective action for all Newport HT70 and Newport HT70 Plus ventilators manufactured since 2010 due to reports that the ventilator may reset spontaneously during normal operation, and without tripping an alarm. “The reported incidence of this condition is approximately one reset in every seven million
FDA Policy/General
Faced with harsh criticism from Democrats about his ties to regulated industry, FDA commissioner nominee Scott Gottlieb told members of the Senate Health, Labor, Pensions & Pensions 4/5 that his work with industry and investing in medical technology projects have taught him “the need for an absolutely objective regulatory
Devices
FDA has cleared a VivaLnk 510(k) for the Fever Scout, a soft, wearable thermometer that continuously measures a person’s temperature. The device offers parents and caregivers the flexibility to continuously and remotely monitor a child or patient’s fever using a smartphone or tablet. The thermometer comes with
Drugs
Amgen has submitted a supplemental BLA for Xgeva (denosumab) to expand its use for preventing skeletal-related events (SREs) in solid tumors to include patients with multiple myeloma. The application includes new data from the pivotal Phase 3 head-to-head 482 study. demonstrated that XGEVA is non-inferior to
Drugs
An 8/15-9/14/16 FDA inspection at a clinical trial site operated by Cassandra Curtis, Indianapolis, IN, found that she failed to follow legal and regulatory requirements governing the conduct of clinical investigations in a Chantix (varenicline tartrate) trial conducted for Pfizer. A just-released 1/27 Warning
Drugs
FDA has released a list of potential signals of serious risks/new safety information identified by the FDA Adverse Event Reporting System for the final quarter of 2016. The report shows that FDA is evaluating the need for action in some instances, has decided that no action is needed now,
Drugs
CDER Office of New Drugs Biomarker Qualification Program co-director Chris Leptak says there are three sources of biomarker information that can affect drug development and potentially facilitate a drug approval. Appearing in an agency video, Leptak says that the three primary sources for biomarker evidence that can be considered
Drugs
India’s Dr. Reddy’s Laboratories says that an FDA inspection led to two more agency concerns with its Srikakulam drug manufacturing facility. The Times of India reports that the company received an FDA-483 outlining the concerns and said it was addressing them. The company did not say what
FDA Policy/General
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Cassandra E. Curtis Indianapolis, IN (1/27): FDA inspected the clinical investigator 9/2016 and a Pfizer-sponsored Phase 4 study “Evaluating the Neuropsychiatric Safety and Efficacy of 12
Drugs
FDA has accepted for review an AbbVie a supplemental NDA for Imbruvica (ibrutinib) in chronic graft-versus-host-disease (cGVHD) after failure of one or more lines of systemic therapy. The therapy is currently approved to treat patients with certain types of non-Hodgkin’s lymphomas, including chronic lymphocytic leukemia/
Devices
FDA has cleared a PTS Diagnostics 510(k) to expand the top range for measurement of HDL cholesterol to 120 mg/dL (3.1 mmol/L) for the company’s PTS Panels lipid panel test strips. The strips now have a measurement range of 20 to 120 mg/dL (0.
Devices
Attorney James Beck (Reed Smith) says a North Carolina federal court has addressed a Catch 22 that existed in the preemption of state tort claims against PMA medical devices. Writing in an online blog post, Beck says that to survive preemption, plaintiffs suing the manufacturers of PMA medical devices have
Drugs
CDER director Janet Woodcock says that multiple forces are driving drug development and the generic drug industry and their regulators need to be ahead of those trends. In a presentation to the 2017 Generic Pharmaceutical Association annual conference, Woodcock identified the forces as international regulatory convergence, advanced manufacturing, rise of
FDA Policy/General
Sens. Ed Markey (D-MA) and Sherrod Brown (D-OH) say they oppose the nomination of Scott Gottlieb to be FDA commissioner because he is too close to drug companies to be effective in fighting the nation’s opioid epidemic. In a news conference, Markey said the record shows that
Drugs
FDA has agreed to an abridged Phase 3 clinical trial for Wockhardt’s WCK 5222, a “superdrug” antibiotic, according to the company. The agency’s decision was based on preclinical and Phase 1 clinical data establishing safety and the clinical scope of efficacy for the drug, it says. WCK 5222
Drugs
Meridian Medical Technologies, a Pfizer company and Mylan’s manufacturing partner for EpiPen Auto-Injector, has expanded a recall of EpiPen (epinephrine injection, USP) and EpiPen Jr (epinephrine injection, USP) auto-injectors to include additional lots distributed in the U.S. and other markets. This recall is based on two
Drugs
Recent Warning Letters show that document control and data integrity (as well as complaint handling and corrective and preventive actions) remain key concerns of FDA investigators, according to an analysis by AssurX. “Today, FDA cGMPs and ISO standards require a document control system that demonstrates product safety and reliability,” the