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
Devices
FDA has cleared a MC10 510(k) for its BioStamp nPoint system, a wireless, biometric data collection platform intended for use by healthcare professionals and researchers for continuous collection of physiological data in the home or traditional healthcare settings. The device is designed for use in clinical trials and research
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-
Devices
FDA has cleared a Ventripoint Diagnostics 510(k) for its VMS+ machine with a four-chamber heart analysis system, intended for use in the analysis of ejection fraction (function) and volumes in any chamber of the heart. “The VMS+ is the first simple echocardiography system to be approved by the
FDA Policy/General
Federal Register notice: FDA has announced a 7/18-19 Blood Products Advisory Committee. On the first day of the meeting, panel members will provide advice regarding bacterial risk control strategies to enhance the safety and availability of platelets for transfusion. On the second day, the panel and members from
Devices
FDA has cleared a BacterioScan 510(k) for its 216Dx Urinary Tract Infection detection system. The rapid automated diagnostic system uses an advanced laser sensor to detect infections, reducing lab turnaround time to about three hours, an improvement of up to 90% compared with traditional testing approaches, according to the
Devices
FDA has cleared a Caliber Imaging & Diagnostics 510(k) for modifications to its Vivascope System, a reflectance confocal microscopy (RCM) device that allows dermatologists to visualize cellular structures within the skin. The device provides high-resolution RCM images of the epidermis down to the supporting stroma in thin, optical
Biologics
FDA has approved a Hospira BLA for Retacrit (epoetin alfa-epbx), the first biosimilar version of Amgen’s Epogen/Procrit (epoetin alfa) for treating anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection. Retacrit is also approved for use before and after surgery
FDA Policy/General
Federal Register proposed rule: FDA has proposed to amend its regulations concerning the classification of products as biologics, devices, drugs, or combination products, and their assignment to agency components for premarket review and regulation. This proposed rule would update combination product regulations to clarify their scope, streamline and clarify the
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.
FDA Policy/General
Federal Register notice: FDA has announced a 7/9 public meeting on “Patient-Focused Drug Development for Chronic Pain” that is intended to provide patients with an opportunity to present their perspectives on the impacts of chronic pain, views on treatment approaches for chronic pain, and challenges or barriers to
FDA Policy/General
Federal Register notice: FDA has announced a Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee meeting 6/20 to review and discuss a list of molecular targets for which evidence or biologic rationale exist to determine their potential relevance to the growth or progression of one or more pediatric
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