Lawmakers to Consider Drug Pricing, Opioid Bills This Week
The House will take up nearly five dozen bills on the opioids crisis and the Senate will hear from HHS Secretary Alex Azar on drug prices in what will be…
Semiannual Agenda Flags Upcoming FDA Regulatory Actions
HHS released its latest regulatory agenda for in-development rulemakings including 20 specific to the FDA. Source: Drug Industry Daily
Stakeholders Urge Tweaks in Draft Guidance on Pregnant Trial Subjects
The FDA’s draft guidance on inclusion of pregnant women in clinical trials needs some fine tuning, according to stakeholders, including more clarity on non-adherence to therapies. Source: Drug Industry Daily
FTC Says Hatch-Waxman Patent Infringement Suits Are Not Antitrust Proof
The Federal Trade Commission filed an amicus brief in the case of Takeda v. Zydus, urging the U.S. District Court of New Jersey to reject the notion that patent infringement…
Australian API Manufacturer Draws FDA Warning Over Quality Investigations
The FDA warned API and finished drug manufacturer IDT Australia for failure to investigate quality issues and for incomplete records. Source: Drug Industry Daily
DOJ Issues New Indictments in Opioid Prescription Scheme
As part of its ongoing campaign against opioid-related fraud, the Justice Department unsealed a superseding indictment Thursday against a CEO and four doctors in connection with a conspiracy to write…
Kroger, Walgreen’s Sue J&J for Suppressing Remicade Biosimilars
Two major drug store chains sued Johnson & Johnson this week alleging the company strong-armed insurers out of covering biosimilars of its immunosuppressant drug Remicade (infliximab). Source: Drug Industry Daily
FDA Seeks Comment on Medical Device Software
The FDA invited stakeholder comments on how it should craft rules governing medical device software under the 21st Century Cures Act. Source: The GMP Letter
India Releases Guidance on Essential Safety and Performance Principles
India’s Drugs Controller General adopted essential principles for safety and performance of medical devices. Source: The GMP Letter
483 Roundup: FDA Flags Six Firms Over Design Controls, Data Integrity
The FDA issued 483s to six device facilities for a variety of deficiencies including design control procedures, data integrity, CAPAs and complaint handling. Source: The GMP Letter
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