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GAO Report on Over-the-Counter Drugs
…However, this all changed in March 2020. As we described in our memo (an updated version of which can be found here), the new legislation reforms the monograph system to…
FDA, Testing, and COVID-19: A “Mid-Mortem”
…Law Blog (Apr. 1, 2020). In short, FDA asserts jurisdiction to regulate clinical laboratory tests, but in most cases exercises “enforcement discretion,” allowing clinical laboratories to innovate and respond quickly…
ACI’s 14th Annual Paragraph IV Disputes (Virtual Conference)
…the ACI conference format has changed from a live, in-person event to an interactive, virtual conference. ACI’s Paragraph IV Disputes Conference provides invaluable professional development opportunities, meaningful networking, and vital…
President Bush Proposes FY2009 FDA Budget; Follow-On Biologics and New User Fee Legislation on Tap for 2008, as Well as Plans to Resurrect FDAAA DTC TV Ad User Fee Program
…to expedite the approval of Abbreviated New Animal Drug Applications. Sponsors of innovator drug products currently pay user fees under the Animal Drug User Fee Act; Reinspection user fees to…
Webinar: Avoiding Drug Substance Patents and Exclusivities – Prodrugs, Deuterated Drugs, and 505(b)(2) Applications
…(Robins Kaplan LLP) will present a primer on strategies for generic drug manufacturers to get around API patents, using the 505(b)(2) application. This route can enable a generic company to…
FDA Finalizes Prior Notice Rule and Issues Draft CPG
…under the IFR, prior notice cannot be submitted more than 5 calendar days before the anticipated date of arrival at the anticipated port of arrival. Under the final rule, this…
The Proposed NIH Framework for Clinical Trials Registration and Results Reporting: A Closer Look
…applicable drug clinical trial for a drug that is approved or licensed and each applicable device clinical trial for a device that is cleared or approved. Following initial approval, clinical…
Pediatric Priority Review Vouchers: A Subtle Upgrade to Renewal Plans
By Alexander J. Varond – On July 10, 2015, the U.S. House of Representatives passed the 21st Century Cures Act. In all, there were 344 “yes” votes and only 77…
FDA Issues Final Rule on Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products
…here. The final rule requires “all applicants of covered approved drugs or biological products—including certain applicants of blood or blood components for transfusion and all manufacturers of covered drugs marketed…
New Legislation Seeks to Incentivize OTC Status for Contraceptives by Granting Priority Review and Waiving PDUFA Application User Fee
…visit her health care provider to receive a prescription. The Allowing Greater Access to Safe and Effective Contraception Act would encourage manufacturers of routine-use contraceptives to file an application with…
Compounding the Animal Drug Debate: FDA Releases Draft Guidance Addressing Compounding of Animal Drugs From Bulk Drug Substances, Raises Specific Questions for which it Seeks Comments, and Requests Animal Bulk Substance Nominations
…Drug Administration (FDA) issued draft guidance on animal drug compounding, including compounding by section 503B outsourcing facilities. FDA also withdrew its vastly different prior Compliance Policy Guide (608.400) for animal drugs promulgated over 12 years…
Strike Two: GAO Releases Statement About DEA’s Administration of the Quota Process and Lack of Coordination with FDA in Setting Quotas for Schedule II Controlled Substances
By Karla L. Palmer – Earlier this week, the GAO released the Testimony of Marcia Crosse, Director, Health Care, before the Senate Caucus on International Narcotics Control. The statement, titled, “Controlled…
CDRH Releases Final Guidance for Expedited Access to Devices for Unmet Medical Needs
By Allyson B. Mullen – On April 13, CDRH released the final guidance document for “Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need…
FDA Formalizes Procedures for Expediting Review of Certain Applications with Breakthrough Therapy Designation
…several months. FDA’s informal policy has now found its way into a Manual of Policies and Procedures entitled “Good Review Practice: Review of Marketing Applications for Breakthrough Therapy-Designated Drugs and Biologics…
FDA’s Draft Guidance on Externally Controlled Trials Answers Some Questions, Leaves Others Unanswered
…a clinical trial. Other challenges related to the selection of outcomes include the differential capture of intercurrent events, and the potential lack of standardization and training regarding clinical outcome assessments….