FDA Policy/General
A 5/2-6/3 FDA inspection at Vetix, Lexington, KY, found multiple violations in the firm’s distribution of animal drug products, according to a 10/12 Warning Letter from the agency’s Cincinnati District Office. Specific concerns on an FDA-483 included: * distributing unapproved new animal drugs — OptiMend,
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Eagle Pharmacy, Inc. Hoover, AL (10/13). FDA investigator inspected the firm’s drug compounding operations 8/2015 and documented serious deficiencies in its practices for producing sterile drug
Devices
Medtronic Neurovascular Products has recalled certain lots of its Pipeline embolization device, Alligator retrieval device and X-Celerator hydrophilic guidewire. The recall also includes the stylet containing UltraFlow flow directed micro catheters and Marathon flow directed micro catheters. The reason for the recall is the potential for the devices’ polytetrafluoroethylene
Drugs
A 5/11-5/29/15 FDA inspection at U.S. Specialty Formulations, Bethlehem, PA, found multiple violations and activities that did not meet requirements under Section 503B of the Federal Food, Drug, and Cosmetic Act for drugs produced by an outsourcing facility to qualify for certain exemptions. A 9/
Biologics
The Center for Biologics Evaluation and Research interim strategic plan for 2017-2019 includes five overarching program goals and a sixth cross-cutting goal. Center director Peter Marks identifies the goals as: * increase the nation’s preparedness to address threats as a result of terrorism, pandemic influenza, and emerging infectious
Drugs
Teva says it will respond 11/4 to an FDA Warning Letter about an inspection at the firm’s drug manufacturing facility in Godollo, Hungary, which has been closed since January. The company says in an SEC filing that the letter cites deficiencies in manufacturing operations and laboratory controls, and
Devices
Three stakeholder trade associations are asking FDA to clarify some aspects of a draft guidance on principles for co-development of an in vitro companion diagnostic device with a therapeutic product. The Biotechnology Innovation Organization says it supports the agency’s efforts to provide a practical regulatory guide for sponsors
FDA Policy/General
Federal Register Notice: FDA has proposed to withdraw ANDA approval for methylphenidate hydrochloride extended-release tablets, and is announcing an opportunity for the holder of the ANDA, Kremers Urban Pharmaceuticals, to request a hearing. After receiving adverse event reports, FDA determined there was an insufficient therapeutic effect of the Kremers
FDA Policy/General
Federal Register Notice: FDA has proposed to withdraw ANDA approval for methylphenidate hydrochloride extended-release tablets, and is announcing an opportunity for the holder of the ANDA, Mallinckrodt Pharmaceuticals, to request a hearing. After receiving adverse event reports, FDA determined there was an insufficient therapeutic effect of the Mallinckrodt’s
FDA Policy/General
Federal Register Notice: FDA has proposed to amend its regulations to revise the list of drug products that have been withdrawn or removed from the market because the drug products or components of such drug products have been found to be unsafe. Drugs appearing on this list may not be
FDA Policy/General
Federal Register Final Order: FDA has classified as Class 2 (special controls) the upper extremity prosthesis including a simultaneously powered elbow and shoulder with greater than two simultaneous powered degrees of freedom and controlled by non-implanted electrical components. The special controls will be part of the codified language for
Drugs
Virtus Pharmaceuticals has filed suit against FDA in middle Florida federal court seeking an order barring enforcement action against the company’s unapproved and allegedly grandfathered potassium chloride drug products. According to the company, after being marketed without an approved NDA for decades, two of Virtus’s competitors gained approval
FDA Policy/General
Federal Register proposed rule: FDA has proposed to implement provisions requiring electronic submission of the device label and package insert of certain home-use devices when these devices are listed with the agency. FDA also plans to make this device labeling available to the public through the Internet and would
FDA Policy/General
Federal Register Final Order: FDA has classified the apical closure device into Class 2 (special controls). The controls will be part of the codified language for the device’s classification. To view this order, click here.
Drugs
President Obama’s “Cancer Moonshot” initiative has released a task force report on implementation plans. One strategic goal, it says, is to catalyze new scientific breakthroughs by “fostering interdisciplinary approaches for elucidating the biological mechanisms underlying cancer onset and treatment; aligning research and care as a seamless and iterative process;
Devices
FDA has cleared a Teleflex 510(k) to market its Arrow Midline with Chlorag+ard Technology, an anti-thrombogenic and antimicrobial peripheral venous catheter designed to minimize common midline catheter complications such as catheter intraluminal occlusion, thrombus accumulation and microbial colonization on the catheter surface for a minimum of 30
Drugs
Sandoz has petitioned FDA asking that it not approve generic copies of GlaxoSmithKline’s asthma inhaler Advair Diskus 100/50 (fluticasone propionate 100 mcg and salmeterol 50 mcg inhalation powder) unless ANDA submissions contain data from a pharmacokinetic (PK) bioequivalence study that is stricter than requirements outlined in an agency
Drugs
FDA reviewers are questioning clinical trial designs in a Serenity Pharmaceuticals NDA for SER120 (desmopressin nasal spray), which is proposed for treating adults with nocturia who awaken two or more times per night to urinate. The submission will be reviewed by the agency’s Bone, Reproductive and Urologic Drugs Advisory
Drugs
Omnicare has agreed to pay $28 million to resolve allegations that it solicited and received kickbacks from Abbott Laboratories in exchange for promoting the anti-epileptic drug Depakote for nursing home patients. In 2012, the government and Abbott entered into a $1.5 billion global civil and criminal resolution that
FDA Policy/General
Federal Register Notice: FDA has made available a guidance on “ANDA Submissions — Prior Approval Supplements Under GDUFA.” The document is intended to assist applicants preparing to submit prior approval supplements and amendments to prior supplements. It also describes FDA’s performance metric goals for such supplements. To view this guidance,
FDA Policy/General
Federal Register Notice: FDA and Johns Hopkins University Center of Excellence in Regulatory Science and Innovation have announced a 11/18 public workshop on “Substitutability of Generic Drugs: Perceptions and Reality” to discuss agency and industry practices related to generic drug postmarket surveillance, research activities, public perceptions on generic drug
FDA Policy/General
Federal Register Notice: FDA has issued a priority review voucher to Sarepta Therapeutics after determining its NDA for Duchenne muscular dystrophy drug Exondys 51 (eteplirsen) met criteria as a rare pediatric disease product. To view this notice, click here.