Drugs
The U.S. Justice Department has announced that medical device manufacturer ev3 has agreed to plead guilty to introducing an adulterated medical device into interstate commerce. The Onyx Liquid Embolic System is approved for use as a device that is surgically injected into blood vessels to block blood flow to
Drugs
FDA has posted a Form FDA-483 citing JCB Laboratories (Wichita, KS) over GMP deficiencies at the drug outsourcing operation. For example, the inspection form said there is no testing to assure that a drug product meets applicable standards of identity, strength, quality, and purity at the time of use.
Drugs
FDA has released a draft guidance entitled “Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment.” The document is intended to assist sponsors by describing the agency’s current thinking about the necessary components of a drug development program for such conditions. It identifies knowledge gaps that represent important
Drugs
FDA has released a guidance entitled “Post-Complete Response Letter (CRL) Meetings Between FDA and ANDA Applicants Under GDUFA.” The document provides recommendations on how such meetings are intended to clarify deficiencies identified in a CRL referencing an ANDA. Post-CRL meetings should be requested in writing by an ANDA
Drugs
FDA has approved a Catalyst Pharmaceuticals NDA for Firdapse (amifampridine) 10 mg tablets for treating adults with Lambert-Eaton Myasthenic Syndrome (LEMS), a rare autoimmune disease that affects about 1 in 100,000 people in the U.S. The most common LEMS symptoms are proximal muscle weakness and fatigue. Symptoms
Drugs
Ten years after launching FDA’s Sentinel medical product safety system, officials are lauding its achievements and future potential. An 11/29 New England Journal of Medicine online perspective notes that Sentinel data are being integrated to inform many CDER regulatory decisions. For example, in the past two years, Sentinel
Drugs
CDER has posted a Manual of Policies and Procedures updated policy on Drug Shortage Management. The manual establishes the Center’s policy and procedures for notification, evaluation, and management of drug shortage situations for all CDER products. It also outlines the responsibilities of the CDER drug shortage staff that are
Drugs
A new Government Accountability Office (GAO) report recommends that FDA ensure that information from orphan drug designation applications is consistently recorded in Office of Orphan Products Development (OOPD) review templates and evaluated by OOPD reviewers when making orphan designation decisions. The GAO review found that the agency does not consistently
Drugs
FDA has issued a drug safety alert to warn about rare but serious cases of stroke and tears in the lining of arteries in the head and neck that have occurred in patients with multiple sclerosis shortly after they received Genzyme’s Lemtrada (alemtuzumab). “As a result, we have added
Drugs
FDA is warning that signs and symptoms of a life-threatening side effect called “differentiation syndrome” are not being identified in patients receiving Celgene’s acute myeloid leukemia drug Idhifa (enasidenib). A safety alert notes that the drug’s prescribing information and patient Medication Guide already contain a warning about
Drugs
The European Medicines Agency (EMA) says that FDA has confirmed the capability of Belgium, Denmark, Estonia, Finland, and Latvia and now has 20 EMA member states it can rely on to replace agency inspections. “Imported products still need to be batch tested until FDA recognizes all EU member states’ authorities
Drugs
Janssen says an FDA draft guidance on adaptive designs for clinical trials of drugs and biologics “provides clear expectations for planning and implementation of adaptive designs in clinical trials.” The company says it believes the guidance will facilitate wider use of the innovative and more efficient designs in drug development.
Drugs
FDA commissioner Scott Gottlieb says failures in policy and economics over many years are responsible for the current increase in drug shortages. Speaking 11/27 at a Duke University Margolis Center for Health Policy conference on “Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions,” Gottlieb described agency
Drugs
FDA has issued 22 new and 41 revised product-specific guidances that when finalized will describe the agency’s thinking and expectations on how to develop generic drugs that are therapeutically equivalent to their respective reference-listed drugs. The agency says that since 2007 it has issued more than 1,
Drugs
A 6/22-6/27 FDA inspection at Corona Doctors Medical Clinics, Corona, CA, found objectionable conditions in the clinic’s role as the sponsor of a redacted clinical investigation. An 11/16 Warning Letter says the inspection was conducted as a part of FDA’s Bioresearch Monitoring Program. Specific
Drugs
Teva Pharmaceuticals has recalled all lots of amlodipine/valsartan combination tablets and amlodipine/valsartan/hydrochlorothiazide combination tablets due to an impurity detected above specification limits in an active pharmaceutical ingredient manufactured by Mylan India. The impurity found in Mylan’s valsartan API is identified as N-nitroso-diethylamine (NDEA), which
Drugs
The Justice Department says Alec Burlakoff, former Insys Therapeutics vice president for sales, has pleaded guilty in Massachusetts federal court to participating in a nationwide conspiracy to bribe medical practitioners to unnecessarily prescribe a fentanyl-based pain medication and defraud healthcare insurers. Burlakoff pleaded guilty to one count of racketeering
Drugs
FDA has approved Astellas Pharma’s Xospata (gilteritinib) tablets for treating adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. The agency also approved an expanded indication for a companion diagnostic, Invivoscribe Technologies’ LeukoStrat CDx FLT3 Mutation
Drugs
FDA has granted six months pediatric exclusivity to Pfizer’s Lyrica (pregabalin). The grant extends the Lyrica market exclusivity period to 6/30/19. The company says Lyrica is currently approved in the U.S. for treating fibromyalgia, diabetic nerve pain, spinal cord injury pain, and pain after shingles in
Drugs
Hyman, Phelps & McNamara is asking FDA not to approve any sNDA to allow Zelnorm (tegaserod maleate) to be marketed unless the sNDA contains substantial evidence of safety and effectiveness for the proposed use in the proposed population under current applicable standards. In the alternative, an 11/21 petition says,
Drugs
Synaptive Medical has recalled its BrightMatter Guide with SurfaceTrace Registration due to a software defect that could potentially result in serious or life-threatening patient harm. An FDA recall notice says that when the device is used with a specific third-party port (the NICO BrainPath device), a software defect
Drugs
The International Council for Harmonization (ICH) approved concept papers and business plans for three new informal working groups and a new discussion group at the ICH meeting 11/10-11/15 in Charlotte, NC. A media release on the meeting says the new working groups are on analytical procedure development,