Drugs
FDA has issued a final guidance entitled “Opioid Use Disorder (OUD): Developing Buprenorphine Depot Products for Treatment,” which outlines the agency’s current thinking about drug development and trial design issues for such products, such as modified-release formulations for injection or implantation. “When combined with the right treatments and
Drugs
FDA has released a draft guidance entitled: “Eosinophilic Esophagitis (EoE): Developing Drugs for Treatment” that assists sponsors with their clinical development of drugs/biologics for treating this condition. The document addresses FDA’s current recommendations for clinical trials for such drugs and the necessary attributes of patients for enrollment, efficacy
FDA Policy/General
Federal Register notice: FDA has announced a 5/1 public workshop entitled “FY 2019 Generic Drug Regulatory Science Initiatives” that is intended to provide an overview of the status of regulatory science initiatives for generic drugs and an opportunity for public input on these initiatives. To view the notice, click
FDA Policy/General
Federal Register notice: FDA has announced a joint 2/12 Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee meeting. The committees will discuss the efficacy, safety, and risk-benefit profile of a Janssen Pharmaceuticals NDA for esketamine 28 mg, a single-use nasal spray device for
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says the International Council for Harmonization (ICH) document Q12, Technical and Regulatory Considerations for Pharmaceutical Product Lifestyle Management, could benefit from additional examples and clarity around the application of the specific tools and enablers introduced by the guidance. In just-released 12/15/
Drugs
Merck says the FDA Framework for FDA’s Real-World Evidence Program, which fulfills the 21st Century Cures Act requirement for the agency to establish a program to evaluate potential use of real-world evidence to help support approval of a new indication for a drug approved under section 505(
Drugs
The Biotechnology Innovation Organization (BIO) says an FDA draft guidance on early drug development for rare diseases and the role of pre-IND meetings “provides important information to drug developers regarding pre-IND meetings to support better the consistency, transparency, [and] efficiency of drug development, and the review of rare
Drugs
FDA has approved a Ablynx BLA for Cablivi (caplacizumab-yhdp) injection, the first therapy specifically indicated, in combination with plasma exchange and immunosuppressive therapy, for treating adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), a rare and life-threatening disorder that causes blood clotting. Patients with aTTP develop extensive blood
Drugs
FDA has issued a draft guidance, Principles of Premarket Pathways for Combination Products, to provide the agency’s current thinking on principles for premarket review of combination products, including how to determine which type of premarket submission is appropriate. “This guidance offers general, high-level information relevant to combination products,
FDA Policy/General
Federal Register notice: FDA has announced a 3/6-7 Vaccines and Related Biological Products Advisory Committee meeting. On 3/6, the panel will discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2019 to 2020 influenza season. On 3/
Drugs
A federal court in western Pennsylvania has entered a consent decree against Ranier’s Rx Laboratory (doing business as Ranier’s Compounding Laboratory) in Jeanette, PA and pharmacist/owner Francis H. Ranier. The court action prohibits Ranier’s and its owner from, among other things, manufacturing, holding, or distributing human
Drugs
A 4/23-4/27/18 FDA inspection at Hangzhou Zhonbgo Industrial Co., Ltd., Hangzhou, Zhejiang, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A just-released 11/27/18 Warning Letter says the specific violations were: * failing to have, for each batch of
Drugs
Pain Therapeutics says that at a 1/31 meeting with FDA to discuss its drug candidate Remoxy ER, it learned that (1) FDA denies making math errors, material mistakes, or misrepresentations during a 6/2018 advisory committee meeting for Remoxy, “despite clear evidence to the contrary”; (2) comparator data is
Drugs
CDER has released its 2018 Drug Trials Snapshot Summary Report, highlighting 59 novel drugs and the extent to which their safety and efficacy data was based on demographic factors. The document says the snapshots posted throughout the year provide information on the diversity of participants in clinical trials and the
Drugs
Sen. Bernie Sanders (I-VT) is asking Catalyst Pharmaceuticals to explain how it set an annual list price of $375,000 for Firdapse, a drug used to treat Lambert-Eaton myasthenic syndrome, a rare neuromuscular disease. Sanders says that for two decades patients received an unapproved version of the same
FDA Policy/General
Federal Register notice: FDA has issued a guidance entitled Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway to assist applicants in developing the Indications and Usage section of labeling for products approved under the accelerated approval regulatory pathway. The document focuses on indications
FDA Policy/General
Federal Register notice: FDA has determined that Genentech’s Esbriet (pirfenidone) film coated tablets (534 mg) was not withdrawn from sale for safety or effectiveness reasons. The determination will allow FDA to approve ANDAs referencing the product if all other legal and regulatory requirements are met. Esbriet is indicated for
Drugs
FDA last year approved 19 new drug and biologic applications, 38 supplemental drug and biologic applications, and four biosimilar applications in oncology. “These advances in anticancer therapy included a landmark approval of the first histology-agnostic, biomarker-defined new molecular entity and approvals based on real-time data review and
Drugs
Genus Lifesciences has petitioned FDA to refuse to accept any submissions by Lannett Company for its 505(b)(2) application for cocaine hydrochloride 4% and 10%. A Genus 2/1 petition says the Lannett submissions are barred by the new chemical entity (NCE) exclusivity arising from FDA approval of the
Drugs
FDA says that Lymol Medical missed a milestone final report due date in the timetable for completion of a postmarketing requirement for sterile talc powder under its NDA. A 1/8 Warning Letter says the failure to comply without demonstrating a good cause for noncompliance violates the law and misbrands
FDA Policy/General
Federal Register notice: FDA has withdrawn approval of ANDA #061579 for nonsterile neomycin sulfate powder for prescription compounding. The basis for withdrawal is that the product is no longer considered safe as labeled due to clinical evidence that systemic exposure to neomycin sulfate can induce significant toxicity, including ototoxicity (manifested
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Hangzhou Zhongbo Industrial Co., Zhejiang, China (11/27/2018): FDA inspected the firm 4/2018 and cited significant GMP violations for finished pharmaceuticals. The company failed to have, for