FDA Policy/General
AbbVie says it is unclear why FDA considers proposed research into disease awareness versus product-specific television ads to be a priority for the public health such that the study is necessary. In comments on the agency’s proposed research, the company reviews agency and industry efforts to regulate advertising.
Devices
FDA has approved a Medtronic PMA for its Pipeline Flex embolization device. Previously indicated for the endovascular treatment of adults with large or giant wide-necked intracranial aneurysms in the internal carotid artery from the petrous to the superior hypophyseal segments, Medtronic says the new indication opens options for patients
Drugs
The International Conference on Harmonization (ICH) has issued a “reflection paper” outlining a strategic approach for developing and enhancing ICH guidelines to support harmonization of scientific and technical standards for generic drugs. As part of the approach, the paper outlines recommendations to develop a series of ICH guidelines on standards
Devices
FDA says it is working to raise awareness of the association between all breast implants, regardless of filling or texture, and breast implant associated-anaplastic large cell lymphoma (BIA-ALCL). An agency letter to healthcare providers says FDA has received reports indicating that patients with breast implants have an increased
Drugs
CDER director Janet Woodcock says agency efforts to modernize its drug regulatory program “will reach a crescendo in 2019 when we’ll be going into implementation. So we’ll begin to see a lot of changes, and I call on all of you for your help and assistance in making
FDA Policy/General
Federal Register notice: FDA has announced a 2/26 Oncologic Drugs Advisory Committee meeting. Panel members are scheduled to review a Karyopharm Therapeutics NDA new for selinexor tablets, indicated for combination use with dexamethasone for treating patients with relapsed refractory multiple myeloma who have received at least three prior therapies
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Eosinophilic Esophagitis: Developing Drugs for Treatment.” The draft is intended to serve as a focus for continued discussions among the Division of Gastroenterology and Inborn Error Products, pharmaceutical sponsors, the academic community, and the public. To view the notice,
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