Drugs
Some 21 health experts are offering what they describe as a comprehensive proposal to ensure universal access to safe, innovative, and affordable medicines, according to a statement from Public Citizen. The plan, published in the British Medical Journal, identifies seven critical areas of reform, with short- and long-term solutions
Drugs
The Pennsylvania Superior Court says a Philadelphia County Common Pleas Court ruled correctly that a suit against Teva and its Cephalon unit alleging illegal off-label promotion of Actiq (fentanyl citrate) oral transmucosal lozenge is preempted under federal law and regulations. The suit claimed that a patient who was prescribed
Drugs
Federal Register notice: FDA is seeking public comments on an information collection extension entitled “Electronic User Fee Payment Request Forms — Form FDA 3913 and Form FDA 3914” (OMB control number 0910–0805). The request forms are designed to provide the minimum necessary information for FDA to review and process a
Drugs
FDA says there were 965 bioresearch monitoring inspections in FY 2017 — 97 performed by CBER, 581 by CDER, and 287 by CDRH. The numbers are included in a metrics report. The report says that common clinical investigator deficiencies were: * failing to follow the investigational plan/agreement or regulations or both;
Drugs
FDA has issued Evolus a complete response letter related to its BLA for DWP-450 (prabotulinumtoxinA) for treating glabellar lines, also known as frown lines, in adult patients. If approved, DWP-450 would be a competitor to Allergan’s Botox. The FDA letter reportedly cited chemistry, manufacturing, and controls-related
Drugs
FDA has accepted for review an Insmed NDA for ALIS (amikacin liposome) inhalation suspension for adult patients with nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex. The agency has granted a priority review and set a user (XXX SPELLING XXX)fee review action target of 9/28. Insmed
Drugs
The federal government has intervened in five whistleblower suits accusing Insys Therapeutics of violating the False Claims Act in connection with marketing its opioid Subsys, a sublingual spray form of fentanyl. A Justice Department news release says Subsys was approved by FDA in 2012 for treating persistent breakthrough pain in
Drugs
FDA researchers say that women were well represented in trials of drugs for hypertension and atrial fibrillation, and over-represented for pulmonary arterial hypertension. However, the representation of women fell below a participation to prevalence ratio of 0.8 for trials in heart failure, coronary arterial disease, and acute coronary
Drugs
FDA has approved a U.S. WorldMeds NDA for Lucemyra (lofexidine hydrochloride) for mitigating withdrawal symptoms in adults who have abruptly discontinued opioid use. FDA says that this is the first non-opioid treatment for managing opioid withdrawal symptoms, but it may only lessen the severity and is only approved
Drugs
FDA says agency scientists have discovered an inaccuracy in some data provided to the agency by a data vendor, IQVIA National Sales Perspectives, including data on certain opioid drug products. An agency statement says FDA found a discrepancy in the IQVIA data that showed a more than 20% drop in
Drugs
FDA has updated a safety alert for all gadolinium-based contrast agents (GBCAs) for MRIs to include an agency-approved new patient Medication Guide. Late last year, FDA required a new class Warning and other safety measures for all GBCAs for MRIs. The Warning concerns retention of gadolinium in patients’
Drugs
FDA has accepted the EndoLogic cardiac safety trial for renzapride is patients with gastroparesis. The company says the study demonstrated no evidence of QTc prolongation in the EKG findings. “FDA views this study as sufficient to characterize renzapride’s QTc prolongation potential at both therapeutic (4 mg/day) and supra-
Drugs
The University of Illinois at Chicago College of Pharmacy says there are steps FDA could take to expedite entry of biosimilars into U.S. markets. In a 5/11 petition, the school says that since passage of the Biologics Price Competition and Innovation Act in 2009, FDA has licensed only
Drugs
Three stakeholders are raising questions about proposed FDA research surveying healthcare professionals on prescription drug promotion. Pharmaceutical Research and Manufacturers of America (PhRMA) says the agency has not followed Paperwork Reduction Act (PRA) procedures that require it to provide adequate means to request and obtain a copy of the survey.
Drugs
A 10/30-11/3/17 FDA inspection at Reine Lifescience, Gujurat, India, found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients. A 5/9 Warning Letter saysthat specific deviations were: * failing to validate and verify the auditability of analytical methods; * failing to exercise sufficient controls
Drugs
A 10/2-10/6/17 FDA inspection at Ei LLC, Kannapolis, NC, found significant violations of current good manufacturing practice (CGMP) for finished pharmaceuticals, according to a just-released 4/16 Warning Letter. Specific violations were: · failing to maintain adequate separate defined areas necessary to prevent contamination or mix-
Drugs
In preparation for the August distribution of PDUFA 6 FY 2019 program fee invoices, FDA has contacted drug manufacturers outlining policy changes under PDUFA 6 and seeking updated contact information. Policy changes described in the document affect (1) what prescription drug products are considered to be the “same product as
Drugs
The Supreme Court of Appeals of West Virginia says there is no cause of action in the state for failure to warn and negligent misrepresentation against a brand-name drug manufacturer when the drug taken by a plaintiff was produced by a generic drug company. The court issued its 5/
Drugs
FDA has cleared a Baxter International 510(k) for the Spectrum IQ Infusion System with Dose IQ Safety Software. The device is designed for bi-directional electronic medical records integration with new features to help ensure the correct medications and fluids are delivered to each patient. Baxter says it provides
Drugs
FDA has approved a UCB supplemental NDA for Briviact (brivaracetam) CV oral formulations indicated as monotherapy and adjunctive therapy in treating partial onset (focal) seizures in patients age four years and older. The expanded indication is based on extrapolation of efficacy data from adults to children, and is supported by
Drugs
FDA has released a 5/15 proposed rule that, once finalized, would bring more transparency to the combination product regulatory process. The proposal is intended to streamline and clarify the appeals process for manufacturers, and align the regulations with more recent legislative and regulatory measures. “These regulations address the process
Drugs
Rep. Tulsi Gabbard (D-HI) and senator Bernie Sanders (I-VT) have introduced legislation to hold pharmaceutical companies accountable for profiting from America’s opioid epidemic. The Opioid Crisis Accountability Act of 2018 would fine drug companies for false marketing and distribution of opioids, and create criminal liability for top