Drugs
A federal jury has convicted former Unlimited Medical Research clinical researcher Jessica Palacio (Miami, FL) for making a false statement to a government investigator related to her role in a clinical trial that studied the effectiveness of asthma drugs in children. The FDA Office of Criminal Investigations case began after
FDA Policy/General
The Department of Justice (DoJ) says its top priority for corporate criminal enforcement is “individual accountability” by targeting the “individuals who commit and profit from corporate crime,” DoJ deputy attorney general Lisa O. Monaco said during a 9/15 program on corporate criminal enforcement in New York. To illustrate the
Biologics
Pfizer says it will file a BLA before year end for its pentavalent meningococcal vaccine (MenABCWY) seeking use in healthy individuals aged 10 through 25 years. The decision to file is based on new positive top-line results from a Phase 3 trial (NCT04440163) that the company says met all
FDA Policy/General
Federal Register notice: FDA has announced an 11/16 Cardiovascular and Renal Drugs Advisory Committee meeting to discuss an Ardelyx NDA for tenapanor hydrochloride tablets and its use in controlling serum phosphorus levels in adults with chronic kidney disease on dialysis. Panel members will be asked to comment on whether
Drugs
FDA has approved a Heron Therapeutics NDA for Aponvie (aprepitant) injectable emulsion, indicated for preventing postoperative nausea and vomiting in adults. The drug is intended to be administered via a single 30-second intravenous injection, and maintains therapeutic plasma concentrations for at least 48 hours, the company says. Approval was
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Q3D(R2) Guideline for Elemental Impurities.” The International Council for Harmonization document provides recommendations for acceptable amounts of the listed elemental impurities for pharmaceutical products, and conducting risk assessments. To view the notice, click here.
Devices
CDRH is updating a 4/27 letter to health care providers to ensure those in operating room settings are aware of a Medtronic recall of its NIM Contact Reinforced EMG Endotracheal Tubes and NIM Standard Reinforced EMG Endotracheal Tubes due to the risk of airway obstructions. “If the tube obstructs
Drugs
HHS has outlined specific FDA projects that will be undertaken as part of President Biden’s recent Executive Order launching a National Biotechnology and Biomanufacturing Initiative (NBBI). According to the department, NBBI will “help drive research and development, improve access to quality federal data, grow domestic manufacturing capacity, expand market
FDA Policy/General
Federal Register notices: FDA has published three notices about its most recent periodic reassessment of the definition of ‘‘small number of animals’’ for minor use in major species. One notice announces that the small number of animals upper limit thresholds for horses and the food-producing major species (cattle, pigs,
FDA Policy/General
Federal Register notice: FDA has determined that intramuscular antibiotic bacitracin for injection, 10,000 units/vial and 50,000 units/vial, was withdrawn due to safety or effectiveness reasons. Such a finding requires the agency to not accept or approve ANDAs (XXX PLURAL XXX)for the drug product. In 2019,
Drugs
The Justice Department says Akorn Operating Company, an Illinois pharmaceutical company, has agreed to pay $7.9 million to resolve a whistleblower’s allegations that it caused Medicare to pay false claims by delaying its request to FDA to switch drugs from prescription to over-the-counter. A department statement
Devices
A MasterControl white paper analyzed medical device data from 2017 through 2019 to determine the most common FDA observations that lead to a form FDA-483 or Warning Letter. The paper says the most common observations involved these processes: * corrective and preventive action; * customer complaints; * purchasing controls; * medical device reporting
Drugs
FDA has granted in part and denied in part a Catalyst Pharmaceuticals 7/8/21 petition asking the agency not to consider any NDA to use amifampridine to treat congenital myasthenic syndromes (CMS) approvable based on a mechanistic argument of efficacy and to require the NDA to include well-controlled,
Drugs
Novartis is petitioning FDA to take specified actions on any ANDAs citing its heart failure drug Entresto (sacubitril and valsartan) oral tablets as the reference-listed drug. The 9/12 petition asks that FDA: * refrain from approving any ANDA referencing Entresto during the three-year exclusivity period covering labeling changes
FDA Policy/General
Speaking 9/15 at an FDA/Organization for Economic Cooperation and Development workshop on illicit trade in health products, FDA associate commissioner Mark Abdoo challenged those present to consider what a global coalition that can explore opportunities for collaboration and identify concrete solutions, including at the policy level, might look
Devices
FDA says the Baxter Healthcare 8/9 recall of 511,728 Clearlink Basic Solution Sets with Duovent is Class 1. An agency notice says the devices, which are used as part of a system to administer drugs and solutions to patients, were recalled after increased consumer reports of leaks. The
Devices
FDA will hold a virtual meeting of the CDRH Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee on 11/1 to discuss “ongoing concerns that pulse oximeters may be less accurate in individuals with darker skin pigmentations.” An agency notice says the committee also will discuss
Drugs
FDA has published an International Conference for Harmonization guidance, Q3D(R2) Elemental Impurities, on controlling within acceptable limits elemental impurities in drug products. The document contains three parts: * the evaluation of the toxicity data for potential elemental impurities; * the establishment of a permitted daily exposure (PDE) for each element of
Drugs
FDA investigators are paying close attention to pharmaceutical water systems during inspections and the agency has cited water deficiencies in about 17% (10) out of more than 60 Warning Letters issued this year, according to CDER Office of Manufacturing Quality director Francis Godwin. Speaking at the FDA/PDA Regulatory conference
Drugs
FDA has approved Mallinckrodt’s Terlivaz (terlipressin) injection for improving kidney function in adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function. The agency says Terlivaz is the first approved medication for this condition. HRS is most common in those with advanced cirrhosis and ascites, fluid buildup in
Drugs
In an amicus brief filed with the 2nd Circuit Court of Appeals, the Washington Legal Foundation (WLF) says the court should affirm a New York federal court’s dismissal of a suit brought by six women against Forest Laboratories over its antidepressant drug Lexapro (escitalopram). In their suit, the women
Drugs
Vanda Pharmaceuticals has filed a lawsuit in the DC District Court against FDA seeking an order to compel it to publish in the Federal Register a notice of opportunity for a hearing related to a complete response letter (CRL) on a supplemental NDA for Hetlioz (tasimelteon) for treating jet lag