FDA Policy/General
CDER’s Office of Prescription Drug Promotion (OPDP) says that while its goal is to provide comments on draft promotional materials within 45 days of the voluntary submission of the materials by sponsors, some recent draft materials “have raised complex issues that required additional review, resulting in review times that
Drugs
Former Insys Therapeutics CEO Michael Babich has pleaded guilty in Massachusetts federal court for his role in a nationwide scheme to bribe physicians to unnecessarily prescribe a fentanyl-based pain medication and defraud healthcare insurers. Late last year, formr company vice president Alec Burlakoff also pleaded guilty in the scheme
Drugs
A 4/9-5/16/18 FDA inspection at the Akorn drug manufacturing facility in Decatur, IL, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 1/4 Warning Letter, announced by the company this week, says specific violations were: * failing to follow appropriate written
Drugs
Sens. Chuck Grassley (R-IA) and Amy Klobuchar (D-MN) have reintroduced their Preserve Access to Affordable Generics and Biosimilars Act to crack down on anti-competitive pay-for-delay drug deals in which branded companies pay their generic competitors not to compete as part of a patent settlement. The
Devices
SightGlass Vision, a medical device company developing spectacle lenses to slow the progression of nearsightedness or myopia in children, has been given an FDA green light to begin a pivotal clinical trial called CYPRESS. The study will evaluate the safety and efficacy of the company’s novel lenses compared to
Drugs
Sen. Bernie Sanders (I-VT) and Rep. Ro Khanna (D-CA) will introduce the Prescription Drug Price Relief Act of 2019 to require the HHS secretary to license generic and biosimilar competition on patented prescription products when they are deemed excessively priced or cost more than the median in Canada,
Drugs
Members of the FDA Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee will discuss 1/11 a sNDA for Takeda’s Uloric (febuxostat) in light of results of an FDA-mandated postmarketing safety trial (CARES) evaluating the drug’s cardiovascular safety. An agency briefing document released in
Drugs
Hyman, Phelps & McNamara has released its annual report highlighting leading cases and settlements from 2018 affecting FDA- and DEA-regulated industries. The report provides a concise summary of the relevant facts and key takeaways of each case and also has a list of “hot-button” cases being monitored this
Drugs
The Consumer Healthcare Products Association (CHPA) says it applauds introduction and passage of H.R. 269, which includes the Over-the-Counter Monograph Safety, Innovation, and Reform Act. The bipartisan measure was approved in the House on a 401-17 vote. CHPA says this is the third time the House
Drugs
FDA commissioner Scott Gottlieb says the agency is launching a new five-year strategy that envisions a more robust Sentinel System that operates as a transformative national resource. Sentinel is a national electronic system for monitoring the safety of FDA-approved drugs and other medical products. Writing with CDER Office
Drugs
FDA 1/4 sent Akorn a Warning Letter related to a month-long inspection at its Decatur, IL manufacturing facility that was conducted in April and May last year. In disclosing the letter, the company says it will work collaboratively with FDA to resolve all issues cited, and it will
Devices
FDA has approved Grifols’ Erytra Eflexis, a benchtop analyzer that performs pretransfusion compatibility testing. The device uses DG Gel technology. “Interchangeable sample and reagent linear racks allow easy, continuous loading of cards, reagents and samples,” the company says. It features “real random access with a capacity of up to 200
Devices
FDA has granted RadioMedix a fast track designation for its investigational diagnostic radiopharmaceutical, [64] Cu-Dotatate, a positron emission tomography (PET) diagnostic agent being studied for somatostatin receptor expressing neuroendocrine tumors. RadioMedix says it has completed a Phase 3 clinical trial of the agent and expects to file an NDA
Drugs
HHS secretary Alex Azar says he and President Donald Trump won’t stop pressuring drug companies until the list prices of drugs come down. Fox Business reports that Azar told the network that the administration will “roll out more regulatory and legislative proposals and we will work with Democrats and
Drugs
FDA has denied an 8/21/13 Public Citizen petition asking that it require a Boxed Warning on labeling for clopidogrel tablets (Bristol-Myers Squibb’s Plavix) addressing the “increased risk of major and minor bleeding with use beyond 12 months following implantation of a drug-eluting coronary artery stents.
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says FDA should exercise caution in implementing any format changes for the National Drug Code (NDC). In a 1/5 comment letter, the trade group says that any changes to the NDC “will require a substantial amount of time and resources to revise
Drugs
FDA commissioner Scott Gottlieb unveiled agency plans 1/8 to create a new Office of Drug Evaluation Science to modernize the drug review process. “We envision a world where we’re going to move toward a much more structured review process where the data will be available in a cloud-
Devices
FDA has denied an 8/25/16 petition asking that the agency either (1) promulgate a final regulation banning electroconvulsive therapy (ECT) devices or (2) maintain the Class 3 classification of these devices and issue a final order establishing the effective date for PMAs for all ECT devices. A 2018
Devices
FDA says it plans to implement the Software Precertification Pilot Program under the de novo pathway as described in a regulatory framework paper. The paper says the goal of this phase of the pilot is to “determine the contours of a possible regulatory model that provides efficient regulatory oversight of
Drugs
In an FDA Voices online report, CDER director Janet Woodcock describes many of the agency’s activities to ensure that drugs it approves are not only effective, but safe. “Safety is a priority both before and after approval, and maintaining the safety of drugs that Americans rely on is a
Drugs
While the U.S. continues to lead worldwide drug research and development, China, India, and South Korea are emerging as important players on the global R&D stage, according to an analysis of new active substances reported in the latest Tufts Center for the Study of Drug Development Impact
Drugs
FDA has granted Novartis a breakthrough therapy designation for crizanlizumab (SEG101) for use in preventing vaso-occlusive crises (VOCs) in patients of all genotypes with sickle cell disease. The company says VOCs are unpredictable and extremely painful events that can lead to serious acute and chronic complications. They happen when