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Senate and House Lawmakers Add to FDA’s To-Do List in Fiscal Year 2016 Appropriations Bills
…addition, the Committee directs the FDA to create an advisory task force, comprised at a minimum of public and private cord blood bankers, transplanters and patients, to provide recommendations to…
As Senate and House Lawmakers Slog Through FDA Appropriations Bills, FDA’s To-Do List Grows
…items that come in different flavors, varieties, or combinations using methods that will enhance accuracy and accessibility to consumers, including ranges, averages, individual labeling of flavors or components, or labeling…
FDA, Testing, and COVID-19: A “Mid-Mortem”
…years of work compressed into mere months. Doing the math, it is physically impossible for FDA, with current staffing levels, to review these submissions in anywhere close to a timely…
Highlights of Drug and Biologic Related Provisions of 21st Century Cures (Part Two)
…or need more information, contact: Frank J. Sasinowski, fsasinowski@hpm.com, 202-737-4287 Josephine M. Torrente, jtorrente@hpm.com, 202-737-7554 David B. Clissold, dclissold@hpm.com, 202-737-7545 James E. Valentine, jvalentine@hpm.com, 202-724-1745 Michelle L. Butler, mbutler@hpm.com, 202-737-7551…
A Victory for Amarin Further Erodes FDA Regulation of Off-label Promotion
…a truthful, non-misleading, and balanced manner. Exhibit A to Letter from Ellen London to Judge Paul A. Engelmayer at 6, Amarin, No. 15-3588 (S.D.N.Y. June 8, 2015). Essentially, FDA agreed…
Proposed Changes to the Device Intended Use Regulation
…for the evaluation of device performance. There are academic studies, journal articles, disease‑focused societies, symposia, conferences, case studies, clinical guidelines, talks by key opinion leaders, and a host of other…
An FDA Warning Letter that Does Not Add Up: OTC Drug Monograph Combination Products With Conflicting Dosing Directions
…the Agency’s OTC drug monograph for cold, cough, allergy, bronchodilator, and antiasthmatic drug products, states: When the time intervals or age limitations for administration of the individual ingredients differ, the…
Orphan Drugs: The Current Firestorm, a Real Evergreening Issue, and a Possible Solution
…bevacizumab (Avastin) Treatment of fallopian tube carcinoma (11/23/2010) In combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for treatment of patients with platinum-resistant, recurrent epithelial ovarian, fallopian tube, or primary…
The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments
…answering questions about, for example, appropriate preclinical models and toxicology studies for novel drugs, design of proof-of-concept studies, or adequate CMC testing to demonstrate safety for first-in-human studies. Direct feedback…
FDA Proposes to Clarify and Update Orphan Drug Regulations
…or effectiveness comparable to the approved drug. For example, to claim that a drug makes a major contribution to patient care through a new formulation or a different route of…
What Device Manufacturers Need to Know at This Time about FDA’s Exercise of Emergency Authority in Response to COVID 19
…that would allow laboratories certified under CLIA to perform high-complexity testing to develop, validate, and use diagnostic tests for the SARS-CoV-2 virus, prior to submission of a request for EUA….
The President Signs 21st Century Cures into Law; Highlights of Drug and Biologic Related Provisions (Part One)
…or need more information, contact: Frank J. Sasinowski, fsasinowski@hpm.com, 202-737-4287 Josephine M. Torrente, jtorrente@hpm.com, 202-737-7554 David B. Clissold, dclissold@hpm.com, 202-737-7545 James E. Valentine, jvalentine@hpm.com, 202-724-1745 Michelle L. Butler, mbutler@hpm.com, 202-737-7551…
The Shutdown: An Update on FDA Activities
…were received prior to October 1. For example, for an application or supplement that requires a fee, if the FY 2014 fee was received on September 30, 2013, FDA expects…
FDA Issues New Guidance on PDUFA User Fee Waivers, Reductions, and Refunds; Guidance Represents the Culmination of 18 Years of FDA Experience
…commercial.” Guidance, at 12. Process for Submitting Requests for Waivers, Reductions, and Refunds. The guidance discusses the timing for submitting requests for waivers, reductions, and refunds, as well as the…
PTE Countdown (Or Not?!?): 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 (Read to a Funky Soundtrack and Vocals by The Pointer Sisters)
…term to extend based on a single Regulatory Review Period (“RRP”), or for a company to request (and be granted) multiple PTEs based on multiple NDA (or BLA) approvals, the…