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FDA’s (Re) (Re) (Re) Evaluation of Bulk Drug Substances for Outsourcing Facilities Under 503B: Is the Third Time a Charm, or Three Strikes, You’re Out?
…FDA also came up with a plan to evaluate bulk substances outsourcing facilities could use in compounding pursuant to the statutory mandate set forth in FDCA Section 503B. That draft…
Stop the Presses: FDA Publishes Policy for Granting Requests to Conduct Expedited Reviews of NDA and BLA CMC Prior Approval Supplements
…drug shortages; special review programs such as the President’s Emergency Plan for AIDS Relief; public health emergencies; certain government purchasing programs; statutory mandates or other legal requirements; events that constitute…
A Future Regulatory Paradigm with Potential Broader Implications
…drive further innovation in response to real world performance and user feedback. Unlike most traditional medical device products, Digital Health has the potential to offer real-time learning through real world…
FDA’s Version of the Scarlet Letter?
…to the general public about this potential impediment to generic drug market competition. The list includes about 50 different drug products all with at least one RLD access inquiry. Of…
Like Ma Bell, I’ve Got the Ill Communications: Final Guidances Issued
…efforts to advance medical product communications to support drug competition and value-based health care (June 12, 2018). Promotional Communication Guidance The Promotional Communication Guidance further explains FDA’s views on manufacturer…
FDA Approves First State Drug Importation Program Under 20-Year-Old Statute, But High Hurdles Remain
…Major Barriers Persist The state plans to start by importing medications for chronic conditions like HIV/AIDS, mental illness, prostate cancer, and urea cycle disorder for patients under the care of…
HP&M’s James Valentine & Ellis Unger @ DIA 2022: FDA Rare Disease Town Hall with CDER & CBER Center Directors, Optimizing Benefit-Risk Assessments, Reflecting on 10 Years of PFDD
Hyman, Phelps & McNamara, P.C.’s James Valentine and Ellis Unger will be presenting at the DIA 2022 Global Annual Meeting held this June 19-23 in Chicago, IL. This meeting brings…
Court Blesses FDA’s Rarely Used Administrative Search Warrant Authority
…or getting a criminal subpoena, there is simply no step that FDA can take to compel interviews of the inspected entity. This case serves as good reminder to all FDA-regulated…
Ensuring the ACA Contraceptive Mandate Meets the Original Intention of Congress
…costly co-payments, can impede access to critical health care, such as contraceptives. In 2010, the Patient Protection and Affordable Care Act (ACA) established a mandate requiring coverage for women’s preventive…
Not-So-Public Material Threat Determinations: If an Incentive Falls in a Forest . . .
…section 319F–2(c)(2)(A)(ii) – or “material threats.” Though the provision allows the withholding of some information that may “reveal public health vulnerabilities” or is otherwise confidential under FOIA (like the existence…
Trump Administration Slaps Pharma Industry with International Reference Pricing Rule (But will it Survive?)
…are competitive with the MFN Drug Payment Amounts.” (85 Fed. Reg. at 762280) The essential features of the MFN Model are outlined below. Performance Period: The MFN Model will be…
The Future of EUAs: What Happens Post-Crisis
…year, trends in competitor litigation, and government priorities post-election. Sign up with the discount code Enforcement15 for 15% off registration. You can learn more about the conference and register here….
The More You Know: FDA Provides Additional Guidance on Biosimilars
…procedural elements related to the submission of an interchangeable biosimilar application. Because the BLA (sometimes called an “aBLA”) submission for a biosimilar and for an interchangeable are the same, industry…
FDA Finalizes Guidance on Obtaining Agency Feedback on Combination Products; Highlights Best Practices for Meeting and Communicating with FDA
…contacted with preliminary or general questions, or to discuss whether an application-based mechanism or CPAM is more appropriate. Meetings with FDA: Traditional vs. CPAM Traditional application-based mechanisms include the pre-submission…
Challenges Face New Federal Drug Importation Law
…Canada (the “Final Rule”). The Final Rule became effective on November 30, but the potential for Canadian drug importation faces significant challenges. First, on November 23, 2020, Pharmaceutical Research and…