FDA Policy/General
CVM 7/24 announced it is issuing its own version of FDA’s eSubmitter tool, to be available next month. In a news release, the Center said the software package will be independent from the FDA eSubmitter program, which is an electronic, question-based submission tool for creating and submitting
FDA Policy/General
Mitsubishi Tanabe Pharma has agreed to acquire NeuroDerm, a clinical stage pharmaceutical company developing drug-device combinations for central nervous system disorders. Mitsubishi will pay $39 per share in cash, which is 79% above currently traded shares. Emergent BioSolutions has agreed to acquire a drug used to treat anthrax from
FDA Policy/General
Former FDA assistant commissioner for compliance policy and recent HHS deputy general counsel David Horowitz has joined Hogan Lovells as a partner in its Washington, DC office. At HHS since 2010, Horowitz oversaw and coordinated legal services supporting FDA, the Centers for Disease Control and Prevention, and the National Institutes
FDA Policy/General
Federal Register notice: FDA has announced three public meetings entitled “Enhanced Drug Distribution Security Under the Drug Supply Chain Security Act.” The meetings are intended to provide members of the pharmaceutical distribution supply chain and other stakeholders an opportunity to discuss and provide input on strategies and issues related to
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension on its “Index of Legally Marketed Unapproved New Animal Drugs for Minor Species — 21 CFR part 516.” Section 572 of the Food, Drug & Cosmetic Act provides for a public index listing of legally marketed unapproved new animal
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Animal Drug User Fee Cover Sheet.” The cover sheet (Form FDA 3546) is designed to collect the minimum necessary information to determine whether a fee is required for the review of an application or supplement or whether
FDA Policy/General
FDA commissioner Scott Gottlieb has appointed CDRH deputy Center director for policy Lauren Silvis as his chief of staff. She had been serving as acting chief of staff since April. Prior to joining FDA in 2015, she was a partner at Sidley Austin. She previously practiced at Covington & Burling.
FDA Policy/General
Federal Register notice: FDA has announced a 9/25 public meeting on “Patient-Focused Drug Development for Hereditary Angioedema.” The meeting is intended to allow the agency to obtain patients’ perspectives on the impact of hereditary angioedema (HAE) on daily life. FDA also is seeking patients’ views on treatment approaches
FDA Policy/General
Federal Register notice: FDA has announced a pilot project program under the Drug Supply Chain Security Act to assist in developing an electronic, interoperable system that will identify and trace certain prescription drugs as they are distributed within the U.S. Under the program, FDA says it will work with
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for a guidance on “Animal Drug User Fees and Fee Waivers and Reductions.” The guidance describes the types of fees and fee waivers and reductions; what information FDA recommends be submitted in support of a request for a
FDA Policy/General
Federal Register notice: FDA is seeking comments on a new information collection associated with “Guidance on E6 (R2) Good Clinical Practice; International Council for Harmonization (ICH)” that amends an ICH guidance entitled ‘‘E6 Good Clinical Practice: Consolidated Guidance’’ (issued in 1996). The amended guidance encourages improved and more-efficient approaches
FDA Policy/General
Federal Register notice: FDA is seeking comments on proposed studies on “Character Space-Limited Online Prescription Drug Communications.” The studies are designed to address the question of whether substantive risk information in character-space-limited communications (e.g., Twitter) is effective in communicating risks when benefit claims are made, or
FDA Policy/General
The Senate Agriculture Appropriations Subcommittee has approved $2.8 billion in discretionary funding for FDA for fiscal year 2018, which is $1 million over the FY 2017 enacted level. Overall, total FDA funding, including user fee revenues, is $5.2 billion, which is $491 million above FY 2017. Like a
FDA Policy/General
Federal Register notice of correction: FDA is correcting a notice that appeared in the Federal Register 10/4/2016. The document announced the withdrawal of approval of 44 NDAs and 158 ANDAs from multiple applicants. That document inadvertently announced withdrawal of approval for the following two ANDAs: ANDA 074123 for
FDA Policy/General
FDA has published a notice on changes made by the 21st Century Cures Act to clarify how the agency processes requests for recognition of voluntary consensus standards. The notice says that any interested party may submit a request for recognition of an appropriate standard established by a nationally or internationally
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Center for Reproductive Health/ Joliet IVF LLC Crest Hill, IL (7/6): FDA inspected the firm in February and cited deviations from the regulations governing human cells, tissues, and
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Adverse Experience Reporting for Licensed Biological Products; and General Records — 21 CFR Part 600.” The regulation requires licensed manufacturers to report each adverse experience that is both serious and unexpected, whether foreign or domestic, as soon as
FDA Policy/General
Federal Register notice: FDA is seeking comments on a new information collection related to a “Draft Guidance for Industry — How To Prepare a Pre-Request for Designation” for feedback from the Office of Combination Products (OCP) on whether a medical product will be regulated as a drug, a device, a
FDA Policy/General
With hundreds of key vacancies to fill at FDA, commissioner Scott Gottlieb has ordered a “comprehensive” review of the agency’s hiring practices and procedures. “We know that our traditional approach to recruiting and hiring is not as efficient as it should be to attract, hire, and retain the types
FDA Policy/General
Draft Guidances for ANDA Bioequivalence Study Designs Federal Register notice: FDA announces the availability of additional draft and revised draft product-specific guidances that provide product-specific recommendations on bioequivalence study designs. 07/14/2017 2 Animal Drugs Withdrawn on Sponsor’s Request Federal Register notice: FDA withdraws approval of
FDA Policy/General
Federal Register notice: FDA has announced the availability of additional draft and revised draft product-specific guidances that provide product-specific recommendations on bioequivalence study designs for potential ANDAs. To view the guidances, click here. To view the notice, click here.
FDA Policy/General
The Trump Administration has renewed its call for Congress to double user fees paid by industry to help with the government’s budgetary activities. In a statement following House passage (see story) of a user fee reauthorization bill (HR 2430), the White House said that to “better support FDA’s