Biologics
Harvard Medical School researchers say that noninferiority clinical trial designs are being applied more commonly and broadly and when appropriately designed and executed can identify innovative treatment alternatives with clinical value. Writing in the New England Journal of Medicine, the authors say that noninferiority trials “have become a major tool
Drugs
FDA has approved a Mylan ANDA for glatiramer acetate injection 40 mg/mL and 20 mg/mL, AP-rated, substitutable generic versions of Teva’s Copaxone, indicated for treating patients with relapsing forms of multiple sclerosis (MS). As part of its ANDAs, Mylan says it submitted “rigorous” side-by-side
Drugs
FDA has issued a guidance, Completeness Assessment for Type 11 API DMFs Under GDUFA, to explain to holders of Type II active pharmaceutical ingredient drug master files (DMFs) that are or will be referenced in an ANDA, amendment to an ANDA, PSA to an ANDA, or a PSA amendment, requirements
Drugs
The Federal Trade Commission (FTC) will hold a workshop, “Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics,” on 11/8, with keynote addresses by FDA commissioner Scott Gottlieb and FTC acting chairman Maureen Ohlhausen. Sessions will cover generic drug markets and supply chain intermediaries, including pharmacy benefit
Drugs
FDA has issued a guidance, ANDA Submissions—Prior Approval Supplements, to assist applicants preparing to submit to FDA prior approval supplements (PASs) and amendments to PASs for ANDAs. The document explains how GDUFA relates to PAS submissions and describes the performance metric goals outlined in the GDUFA 1 and 2
Drugs
Federal Register: FDA has announced a 10/20 public workshop on “Topical Dermatological Generic Drug Products: Overcoming Barriers to Development and Improving Patient Access.” At the meeting, officials will provide an overview of current regulatory science initiatives related to generic topical dermatological drug products, solicit public input on scientific barriers
Drugs
FDA has issued a guidance, M4 Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use, as part of a series of guidances providing recommendations for applicants preparing the Common Technical Document for the Registration of Pharmaceuticals for Human Use (CTD) for submission to FDA. The
Drugs
FDA says hemorrhagic occlusive retinal vasculitis (HORV) has been observed in dozens of patients who have receive intraocular injections of vancomycin formulations toward the end of otherwise uncomplicated cataract surgeries. A Compounding Drug Alert discusses an adverse event report received 8/14 from a doctor about a patient who was
Drugs
A 1/23-1/26 FDA inspection at Dasan E&T Co., Kyonggi-do, Korea, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 9/22 Warning Letter. Specific violations cited in the letter included: * failing to have, for each batch of
Drugs
FDA has issued two draft guidances dealing with changes resulting from the GDUFA 2 reauthorization agreement. The first guidance, ANDA Submissions—Amendments to Abbreviated New Drug Applications Under GDUFA, explains to applicants how the review goals established as part of the Generic Drug User Fee Amendments reauthorization apply to amendments
Drugs
FDA has denied without comment on whether it will ultimately take any of the requested actions, an Apotex 5/3/17 petition that asked the agency to take four specific actions regarding proposed biosimilars to Amgen’s Neulasta (pegfilgrastim). The denial letter says that because FDA is mandated by law
Drugs
The 9th Circuit Court of Appeals has denied a Gilead request to rehear or rehear with the entire court a whistleblower case involving three of the company’s HIV drugs that was initially thrown out by a California federal court, but then was granted by the appeals court. The company’
Drugs
FDA is making changes to ease patient access to experimental therapies under its expanded access program, according to commissioner Scott Gottlieb. Testifying before a House Energy and Commerce Health Subcommittee hearing 10/3, he noted that current regulations require physicians to obtain full IRB approval in order to treat a
Drugs
Federal Register notice: FDA has announced a 10/18 Endocrinologic and Metabolic Drugs Advisory Committee meeting. Panel members are scheduled to discuss the safety and efficacy of a Novo Nordisk NDA for semaglutide injection as an adjunct to diet and exercise to improve glycemic control in adults with Type 2
Drugs
FDA has released two guidances as part of its initiative to make it easier to introduce generic copies of complex drugs. The first is a draft guidance on “Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA” that is intended to give advice on meeting requests for
Drugs
Federal Register notice: CDER is announcing support for version 1.1 of “Clinical Data Interchange Standards Consortium (CDISC), Analysis Data Model Implementation Guide,” an update to the FDA Data Standards Catalog. The agency is encouraging sponsors and applicants to use the guide when investigational study data is provided in regulatory
Drugs
A recent corporate integrity agreement (CIA) between Aegerion Pharmaceuticals and HHS’ Office of Inspector General (OIG) provides “insights into the safeguards OIG likely expects pharmaceutical manufacturers to implement with regard to their relationships with independent charitable foundation patient assistance programs,” attorneys from Hogan Lovells write in a 9/28 client
Drugs
FDA has issued Intellipharmaceutics International a complete response letter on its Rexista (oxycodone hydrochloride) extended-release tablets for treating pain. The agency’s letter provided certain recommendations and requests for information, including that Intellipharmaceutics complete the relevant Category 2 and Category 3 studies to assess the product’s abuse-deterrent
Drugs
FDA has released the FDA-483 issued following a 9/11-9/19 inspection at Divi’s Laboratories, Andhra Pradesh, India, an active pharmaceutical ingredient (API) manufacturer. Specific observations listed were: * failing to test individual batches of final API for conformity with all appropriate specifications such as purity, strength, and
Drugs
FDA is publishing a guidance, Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization, with recommendations for drug companies interested in participating in a program involving submission of emerging manufacturing technology. The document finalizes a guidance issued 12/23/15. The agency says the program is open to companies
Drugs
FDA has approved an Eli Lilly NDA for Verzenio (abemaciclib) for treating adult patients who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer that has progressed after taking endocrine therapy. Verzenio is approved to be given in combination with fulvestrant.
Drugs
FDA commissioner Scott Gottlieb says the agency is extending Risk Evaluation and Mitigation Strategy (REMS) requirements that now apply to extended-release/long-acting (ER/LA) opioid formulations to cover immediate-release (IR) formulations as well. Writing in an FDA Voice blog post, Gottlieb says FDA notified 74 manufacturers of