Drugs
FDA has denied a Vifor Fresenius Medical Care Renal Pharma 7/12 petition asking that FDA not approve a pending sNDA for Auryxia (ferric citrate) submitted by Keryx Pharmaceuticals. The petition asked that FDA only consider the proposed iron deficiency anemia (IDA) indication after Keryx submits an additional NDA containing
Drugs
FDA commissioner Scott Gottlieb says the agency is looking at steps it can take to reduce the likelihood that branded drug companies can use the existence of a Risk Evaluation and Mitigation Strategy (REMS) as a way to slow the entry of generic competition. In a statement, Gottlieb said the
FDA Policy/General
Federal Register notice: CDER is seeking comments on a proposed “Analysis Data Reviewer’s Guide” (ADRG) template that was developed under an ongoing collaboration with the Pharmaceutical Users Software Exchange (PhUSE), an independent, non-profit consortium addressing computational science issues. The template is under review to determine whether the Center
Drugs
The Better Business Bureau’s National Advertising Division (NAD) has referred advertising claims made by Synergy Pharmaceuticals to the Federal Trade Commission after the drug company declined to participate in a NAD proceeding. NAD says the Synergy claims for its Trulance (plecanatide) chronic idiopathic constipation prescription drug made in online
Drugs
The use of real-world evidence (RWE) and data is growing and assuming great importance for drug companies in drug development, patient safety, and commercialization. That’s a key takeaway from a Tufts Center for the Study of Drug Development survey of 30 drug companies to assess current and planned
Drugs
Stericycle Expert Solutions says that medical device recalls fell 39% to 167 in the third quarter of 2017. It was the lowest quarter for the industry since the fourth quarter of 2011. Despite the steep drop, however, the group says, recalled units increased 1% to 68 million. “The main reason
FDA Policy/General
Federal Register notice: FDA has made available a guidance on “Recurrent Herpes Labialis (RHL): Developing Drugs for Treatment and Prevention.” The document is intended to assist sponsors in all development phases of development and it also addresses prevention of RHL. It outlines the types of nonclinical studies and clinical trials
FDA Policy/General
Federal Register notice: FDA has submitted to OMB a new proposed information collection supporting its “Draft Guidance for Industry and Review Staff on Target Product Profile — A Strategic Development Process Tool.” Target product profiles (TPPs) can be prepared by a sponsor and then shared voluntarily with the appropriate FDA review
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision for its “Guidance for Industry on Expedited Programs for Serious Conditions — Drugs and Biologics OMB Control Number 0910 – 0765.” The guidance provides a single resource for information on FDA’s policies and procedures related to the following expedited
Drugs
FDA says it has received an adverse event report that two patients developed tissue erosion at the injection site following the administration of an injectable glutamine, arginine, and carnitine (GAC) product that was compounded by United Pharmacy, West Palm Beach, FL. The adverse event report indicated that a sample of
Drugs
FDA has approved a Collegium Pharmaceutical supplemental NDA to enhance the label for Xtampza ER (oxycodone extended-release), an abuse-deterrent, extended-release opioid, for managing pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The sNDA approval,
Drugs
Commenting on Amgen’s federal court suit challenging FDA’s denial of six-months pediatric exclusivity for its Sensipar (cinacalcet), Yale Law School professor Jeanie Kim says in a JAMA Network online article that courts should defer to the agency’s current policy that links “fairly respond” to a study’
Drugs
FDA has approved a Roche PMA for the Ventana ALK (D5F3) CDx Assay as a companion diagnostic to identify anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer patients eligible for treatment with Genentech’s (a Roche subsidiary) Alecensa (alectinib). Alecensa gained approval 11/7 based on data from
Devices
A 9/18-10/16/14 FDA inspection found objectionable conditions at a clinical site operated by Dr. William Domb in Upland, CA, who was sponsor/investigator of the significant risk clinical study entitled “Expectations for IRB Research Associations and Oxygen/Ozone Simplified and Suggested Research Treatment Protocols: A Historical
Drugs
A Federal Trade Commission Bureau of Competition report says that for FY 2015, drug companies filed 170 agreements as final resolution of patent disputes between brand and generic drug manufacturers, including 14 settlements that potentially involved pay-for-delay because they contained both explicit compensation from a brand manufacturer to
Drugs
A 5/15-5/19 FDA inspection at Guangdong Zhanjiang Jimin Pharmaceutical Co., Zhanjiang City, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 10/30 Warning Letter. The letter says the firm also manufactures and distributes a product for over-the-
Drugs
The 6th Circuit Court of Appeals has upheld on a 2-1 vote a lower federal court’s dismissal of a whistleblower suit against Bristol-Myers Squibb that was based on allegations of off-label promotion. Attorney Andrew Hull (Hyman, Phelps & McNamara) writes in his firm’s FDA Law
FDA Policy/General
Federal Register notice: FDA has classified genetic health risk assessment systems into Class 2 (special controls). The action was taken in response to a 2016 de novo request submitted by 23andMe for its Personal Genome Service Test. To view the notice, click here.
Drugs
FDA has published a guidance on “Recurrent Herpes Labialis: Developing Drugs for Treatment and Prevention” that discusses the overall development program and clinical trial designs for drug products with an antiviral mechanism of action used to prevent or treat the condition. The guidance does not address drug products used to
FDA Policy/General
Federal Register proposed order: FDA is proposing to reclassify the needle destruction device, renaming the device to “sharps needle destruction device,” from Class 3 into Class 2 (special controls), subject to premarket notification. FDA is also identifying the proposed special controls that the agency believes are necessary to provide a
Drugs
Sen. Kamela Harris (D-CA) says she has launched an investigation into the drug maker Alkermes and its efforts to artificially boost sales of Vivitrol, a treatment for opioid addiction. In a statement, Harris referenced news reports indicating that the company attempted to boost sales of its own product while
FDA Policy/General
Federal Register notice: FDA has classified the total 25-hydroxyvitamin D mass spectrometry test system into Class 2 (special controls). The action was in response to a 3/20 de novo request by AB Sciex for its Vitamin D 200M Assay for the Topaz System. To view the notice, click