Drugs
A 12/14-12/18/15 FDA inspection at Srikem Laboratories, Mumbai, India, found significant deviations from current good manufacturing practice regulations for active pharmaceutical ingredients, according to an 11/8 Warning Letter. Specific deviations included: * failing to have laboratory control records that include complete data derived from all laboratory
Drugs
FDA has issued two guidances in partial fulfillment of requirements under the 2014 Sunscreen Innovation Act. The first guidance, Nonprescription Sunscreen Drug Products—Safety and Effectiveness Data, addresses the agency’s thinking about data needed to determine whether a nonprescription over-the-counter sunscreen ingredient or combination of ingredients evaluated
Drugs
Attorneys Joanne Hawana and Benjamin Zegarelli (Mintz Levin) say that five recurring themes arose from a recent two-day FDA hearing on the appropriate regulatory approach to manufacturers’ communications about off-label uses for their marketed products. Writing in an online blog post, they summarize the themes as: * Use different
Drugs
A 10/5-10/13/15 FDA inspection at CP Pharmaceuticals, Wrexham, UK, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to an 11/16 Warning Letter. Specific violations included: * failing to follow appropriate written procedures designed to prevent microbiological contamination of drug products
Drugs
FDA has posted a guidance on “Safety Testing of Drug Metabolites” that provides recommendations to industry on when and how to identify and characterize drug metabolites whose nonclinical toxicity needs to be evaluated. “The safety of drug metabolites may need to be determined in nonclinical studies because these metabolites are
Drugs
The International Probiotics Association has petitioned FDA asking that it amend its regulations to require the quantitative amount of probiotic ingredients in a dietary supplement to be presented in terms of colony forming units (CFUs) instead of by weight. “The amendment to the regulations requested here would help ensure that
Drugs
FDA has sent Antera Therapeutics an untitled letter due to promotional claims on the company’s Web site that make Aralyte Starter Kit an unapproved biological product. Aralyte is described as an all natural peanut protein formula. Claims on the Web site demonstrate that the product is intended to prevent
Drugs
Sanofi Pasteur has decided to discontinue making TheraCys (BCG live attenuated), indicated for treating non-muscle invasive bladder cancer. In an email sent to urologists late last week and obtained by Forbes contributor Benjamin Davies, the company notes how it brought the product back online after resolving GMP issues at
Drugs
Cantrell Drug Co. has recalled certain unexpired sterile drug products due to lack of sterility assurance. Affected products include calcium chloride, fentanyl citrate, glycopyrrolate, heparin sodium, and hydromorphone, among others. “Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may
Drugs
Apricus Biosciences says it has received FDA feedback that supported the company’s strategy for addressing deficiencies contained in the 2008 Complete Response Letter on its Vitaros (alprostadil topical cream) NDA for treating erectile dysfunction. “Based upon our expert panel’s review of the FDA’s feedback, and the available
Drugs
FDA has appealed to the DC Circuit Court of Appeals a district court ruling remanding to the agency for further consideration a case brought by Ferring seeking five years of exclusivity for its Prepopik (magnesium oxide, anhydrous citric acid, and sodium picosulfate) fixed-dose combination drug, based on the fact
Drugs
Neos Therapeutics has submitted an NDA for its Amphetamine XR oral suspension drug candidate, NT-0201, an attention-deficit hyperactivity disorder medication based on the company’s proprietary modified‐release drug delivery technology platforms. Neos says it is also planning to resubmit by year end its NDA for Cotempla XR-
Drugs
Former FDA Office of Generic Drugs deputy director turned consultant Gordon Johnston, who pled guilty in June for being part of an insider trading scheme (see story), has agreed to a settlement with the SEC. Under the agreement, Johnston must return the illegal profits (disgorgement) and pay a civil penalty,
Drugs
An HHS inspector general’s (IG) report on the top management and performance challenges facing the agency says that FDA’s challenges include drug compounding, the complex drug supply chain, improper marketing activities, and food safety. The report describes each challenge, the progress made in addressing it, and what remains
Drugs
The Government Accountability Office (GAO) says that FDA has taken steps to implement its regulatory responsibilities to oversee drug compounding, but states and stakeholder organizations have said there are some challenges. A GAO report says FDA has issued numerous draft and final guidances related to drug compounding and has conducted
Drugs
The International Council on Harmonization adopted at its 11/5-10 meeting an amendment to its guideline on good clinical practice to encourage sponsors to implement improved oversight and management of clinical trials, while continuing to ensure protection of human subjects participating in trials and clinical trial data integrity. A
Drugs
The federal government has arrested former Valeant Pharmaceuticals executive Gary Tanner and former Philidor Rx Services CEO Andrew Davenport for engaging in a multimillion-dollar fraud and kickback scheme. Philidor was a specialty mail-order pharmacy that was formed in 2013 with the assistance of Valeant, including provisions for financing,
Drugs
FDA has issued a draft guidance, BCG-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment, to assist sponsors in the clinical development of drugs, including biologics, to treat patients who have bacillus Calmette-Guerin (BCG)-unresponsive nonmuscle invasive bladder cancer (NMIBC). The document says that many of
Drugs
FDA has approved an Endoceutics NDA for Intrarosa (prasterone) to treat women experiencing moderate to severe pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. Intrarosa is the first FDA-approved product containing the active ingredient prasterone, which is also known as dehydroepiandrosterone
Drugs
FDA has released a guidance on “Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments,” a revision that answers common questions from the generic drug industry and other interested parties on GDUFA user fees. The document updates and clarifies the responses in some cases
Drugs
The Generic Pharmaceutical Association (GPhA) says that the new Generic Drug User Fee Agreement (GDUFA) program has had significant impact on both the industry and the agency and there have been enormous changes to ensure the success of all parties. “As we transition from GDUFA 1 into GDUFA 2, we
Drugs
FDA says that the two requests in a 10/31/14 Omthera Pharmaceuticals petition and 11/2/15 supplement have already been granted by previous agency action. The petition asked that FDA (1) grant Omthera’s request for five-year new chemical entity (NCE) exclusivity for its Epanova (omega-3-