Drugs
A new Government Accountability Office (GAO) report finds that FDA has ongoing efforts to help drug manufacturers identify the circumstances under which they could broaden clinical trial eligibility criteria to include patients who are commonly excluded, such as pediatric patients and patients with impaired liver and kidney function, without compromising
Drugs
CDER director Janet Woodcock is emphasizing the need for drug compounding outsourcing facilities to appropriately label their drugs with adverse event reporting information and to report events to FDA, or face regulatory and enforcement action if they do not. “We remind outsourcing facilities to develop thorough procedures to compile and
Drugs
CDER director Janet Woodcock says addiction currently is the most serious threat to public health. In a 9/6 interview with the Los Angeles Times, Woodcock said the opioid abuse is improving at the moment, but there are many other concerns: “Alcohol abuse. Poly-drug abuse, when people combine multiple
Drugs
FDA has approved Boehringer Ingelheim Pharmaceuticals’ Ofev (nintedanib) capsules to slow the rate of decline in pulmonary function in adults with interstitial lung disease associated with systemic sclerosis or scleroderma. Approval was based on data in 576 patients ages 20-79 with the disease. “Patients received treatment for 52 weeks,
Drugs
FDA has issued a guidance, Drugs for the Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy from Adults to Pediatric Patients 2 Years of Age and Older, with recommendations to sponsors on clinical development of drugs for treating partial onset seizures in pediatric patients. Specifically, the document addresses the
Drugs
FDA has issued a grant to VeraSci to conduct further research on its virtual reality functional capacity assessment tool (VRFCAT). The company says the VFRCAT has been accepted into the agency’s clinical outcome qualification program as a measure of functional capacity for schizophrenia treatment trials. It says the project
Drugs
The Justice Department says Mallinckrodt has agreed to pay $15.4 million to resolve claims that when it was known as Questor it paid illegal kickbacks to doctors in the form of lavish dinners and entertainment to induce prescriptions for its H.P. Acthar Gel from 2009 through 2013. The
Drugs
The Combination Products Coalition says it has some concerns and suggestions for improvement in a draft FDA guidance on instructions for use (IFU) in patient labeling for combination products. The coalition’s comment letter recommends that the agency revise the document to: * clarify that the final layout and content of
Drugs
An analysis by the Pew Charitable Trusts finds that “it is clear that there are too few [antibiotic] drugs in development to meet current and anticipated patient needs.” The Pew issue brief shows 42 new antibiotics currently in development. “These drugs would potentially address many, but not all, resistant bacteria,
Drugs
FDA has issued a guidance, Evaluation of Internal Standard Responses during Chromatographic Bioanalysis: Questions and Answers, with recommendations for sponsors, applicants, and contract research organizations about internal standard (IS) response variability in chromatographic analytical data submitted in INDs, NDAs, ANDAs, BLAs, and supplements. The document says that chromatographic analytical methods
Drugs
Former FDA principal deputy commissioner Rachel Sherman has been appointed to Aptinyx’s board of directors. The clinical-stage biopharmaceutical company is developing therapies for treating brain and nervous system disorders. “The company’s NMDA receptor platform, rooted in novel chemistry and a unique mechanism for modulation of a critical
Drugs
FDA says it recently approved changes to Gilead’s Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) labeling to include new dosage forms and use in pediatric patients three years of age to less than 12 years of age. An online post summarizes the changes for each product. Sovaldi is now
Drugs
Researchers from the University of Pittsburgh and Veterans Health Administration (VHA) say that prescriptions for Pfizer’s Chantix (varenicline) fell following FDA drug safety communications and a Boxed Warning. The research, published online at JAMA Network Open, says that FDA drug safety communications often are based on limited evidence of
Drugs
An new study in the Pharmacotherapy journal by CDER drug safety officials and academic researchers suggests that FDA’s move to a consumer-friendly adverse event reporting form has “contributed positively to both the quality and quantity of consumer reports.” The move to the consumer voluntary reporting form (ConVR) occurred
Drugs
Dalhousie University Health Law Institute director Matthew Herder says that so far FDA’s power to withdraw approval of a drug if its manufacturer fails to produce useful post-approval required clinical studies on time is an “empty threat.” Herder interviewed senior FDA officials involved in the approval of Sarepta’
Drugs
A 2/4-2/8 FDA inspection at Polimeros y Servicios, San Jose, Costa Rica, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and other issues. An 8/22 Warning Letter says the violations were: * failing to have, for each batch of drug product, appropriate
Drugs
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Balamurali K. Ambati, Eugene, OR (8/13): FDA inspected the clinical investigator in April and cited Ambati for not adhering to applicable statutory requirements governing the conduct of clinical
Drugs
The drug industry has dropped to the bottom of the Gallup Poll’s annual Work and Education Poll, taking that position away from the federal government in terms of its net-positive score. Pharma received a 27% total positive ranking, 15% neutral, and 58% total negative, for a -31 net
Drugs
Under terms of a consent decree entered by a Tennessee federal judge, Basic Reset and Biogenyx must stop distributing drugs, dietary supplements, and medical devices until they comply with the Federal Food, Drug, and Cosmetic Act and other requirements in the decree. According to a Justice Department complaint filed with
Biologics
A 3/4-3/8 FDA inspection at Stemell, Inc., San Juan Capistrano, CA, found current good manufacturing practice (CGMP) and current good tissue practice (CGTP) violations in the firm’s manufacturing of products derived from human umbilical cord blood and umbilical cord for allogenic use. An 8/28 Warning
Drugs
CDER deputy center director for clinical science Robert Temple says the agency and drug industry are in the third age of drug development — the age of individualization. Speaking last month at a precision dosing workshop at the agency’s Silver Spring, MD headquarters, Temple noted that the previous ages covered
Drugs
An FDA 3/18-3/22 inspection at Yino, Inc., Chongqing, China, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (API). An 8/12 Warning Letter says the deviations were: * failing to transfer all quality or regulatory information received from the API manufacturer to