Drugs
Attorney Lindsay Breedlove (Pepper Hamilton) says that a Massachusetts federal court rejected efforts by a union to certify a class action against Forest Laboratories under the Racketeer Influenced and Corrupt Organization Act (RICO). In a Washington Legal Foundation Legal Opinion Letter, Breedlove writes that although the court found that the
Drugs
User fees collected by FDA from drug manufacturers to fund drug reviews total $7.67 billion since 1992, according to an Avalere Health analysis. The company looked at the three types of prescription drug user fees — product fees paid for each product being sold on the market, establishment fees paid
Drugs
FDA has given the green light for Female Health Co. and Aspen Park Pharmaceuticals to file a 505(b)(2) NDA for tamsulosin DRS (Delayed Release Sachet), indicated for treating benign prostatic hyperplasia. “Our product is a novel powder which utilizes a proprietary extended release formulation of the existing active
Drugs
A 6/15-6/18 FDA inspection at Zhejiang Medicine Co., Xinchang Pharmaceutical Factory, Zhejiang, China, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients, according to an 8/4 Warning Letter. Specific deviations included: * failing to have laboratory control records that include complete data
Drugs
The Supreme Court has been asked to review a Federal Circuit Appeals Court ruling that a statutory safe harbor does not apply to a generic drug manufacturer’s bioequivalence testing performed only as a condition of maintaining FDA approval. Attorneys Amy Hayden and Ewa Davison (Fenwick & West) write in
Drugs
A 6/22-7/10 FDA inspection at Noven Pharmaceuticals, Miami, FL, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to an 8/5 Warning Letter from the agency’s Florida District Office. Specific violations included: * failing to establish and document the accuracy, sensitivity,
Drugs
FDA says it has placed an Import Alert on all products produced by Laxachem Organics, Maharashtra, India, due to its refusal to allow FDA investigators to inspect its facility. The alert stops all of the company’s products from entering the U.S., according to an agency statement. FDA says
Drugs
The FDA Group says that to prevent potentially damaging consequences when things go wrong, manufacturers need to take on effective remediation projects that not only identify the root causes of particular problems, but put comprehensive plans in place to remedy them and communicate the improvements to FDA effectively. In a
Drugs
AstraZeneca says that a draft FDA guidance on quality attribute considerations for chewable tablets does not have any text related to tablet hardness or chewing difficulty on stability. “Tablets may harden over time or can turn into a moist gritty mass as superdisintegrants can pick up moisture and soften the
Drugs
FDA believes proposed recommendations for reauthorizing the Prescription Drug User Fee Act (PDUFA) for fiscal years 2018 through 2022 will provide strong and a comprehensive set of enhancements and refinements to the user fee program. Speaking at a 8/15 user fee pubic meeting, CDER director Janet Woodcock said she
Drugs
CDER has posted a draft guidance on “Regulatory Classification of Pharmaceutical Co-Crystals” that provides sponsors with information on the appropriate regulatory classification of pharmaceutical co-crystal solid-state forms. The document also provides information about the data that applicants should submit to support the appropriate classification of a co-
Drugs
FDA has launched an new online Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). The site features new, user-friendly search options that help users customize their research experience, the agency says. The Orange Book identifies drug products approved on the basis of safety and effectiveness data, and it
Drugs
FDA has granted Tivorsan Pharmaceuticals an orphan drug designation for TVN-102 (biglycan) and its use in treating Duchenne Muscular Dystrophy. The company says it is on track to submit an IND and begin clinical trials in 2017. TVN-102 is described by Tivorsan as a small, naturally occurring extracellular
Drugs
Helsinn and MEI Pharma have entered into a licensing, development and commercialization agreement for pracinostat, a Phase 3-ready drug candidate for treating acute myeloid leukemia (AML) and other potential indications. Under the agreement, Helsinn will get exclusive worldwide rights, including manufacturing and commercialization rights, and will be responsible for
Drugs
CDER has posted a new internal policy on drug sponsors who seek approval for a “Change in Hard Gelatin Capsule Shell Supplier.” When an applicant changes the supplier of a hard gelatin capsule shell, with no change in capsule composition or appearance, the information should be submitted in an annual
Drugs
Endo International says that after meeting with FDA 8/11 it has decided to withdraw its supplemental NDA seeking specific abuse deterrent labeling for Opana ER (oxymorphone HCl extended-release tablets). The sNDA covered a formulation using the company’s INTAC Technology and included studies designed to evaluate the formulation’
Drugs
FDA has announced a 9/25 public workshop on “Facilitating Anti-infective Drug Development for Neonates and Young Infants” to discuss the scientific challenges with developing such products. Discussions will focus on challenges related to enrolling neonates and young infants in clinical trials, strategies to assess central nervous system penetration
Drugs
Ton Shen Health of Chicago, IL, has recalled its “DHZC-2” tablets because they have the potential to be contaminated with elevated levels of lead. One illness has been reported to date in connection with this problem, according to a recall notice. The sale of the product has been suspended
Drugs
FDA has completed a comprehensive review of safety information related to fatty acid amide hydrolase (FAAH) inhibitors under development in the U.S and determined that toxicity seen with a similar drug in France does not extend to others in the drug class. Earlier this year, the agency and European
Drugs
The Clinical Trials Transformation Initiative (CTTI) has published two sets of recommendations intended to advance clinical trials for antibacterial drug development to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP). A CTTI statement says that the new recommendations “outline innovative approaches to designing clinical trials for
Drugs
Attorney Mark Schwartz (Hyman, Phelps & McNamara) says it is “troubling that FDA has been so delinquent in developing a framework to more objectively assess the strength of quality systems throughout the [drug] industry, which could have identified such problems in their infancy, and done so more accurately.” Schwartz’ comment
Drugs
FDA has published a draft guidance, Dietary Supplements: New Dietary Ingredient Notifications and Related Issues: Guidance for Industry, to help manufacturers and distributors of dietary ingredients and dietary supplements decide whether to submit a premarket safety notification to FDA for a product that is or contains a new dietary ingredient