On March 28, 2022, FDA transmitted its justification to Congress for its Fiscal Year 2023 budget. This document contains a number of legislative proposals, including three proposed amendments to the accelerated approval statutory provisions in section 506(c) of the Federal Food, Drug, and Cosmetic Act. …
End-of-Phase 2 (EOP2) is, in our view, one of the most critical moments in drug development. It’s the moment at which a drug sponsor selects, and seeks FDA agreement on, its critical Phase 3 study parameters: dose, eligibility criteria and endpoints, to name a few. …
This sentiment is being exchanged by many with family, friends and colleagues looking forward to what we all hope is a near future in which we meet in person for work, play and everything else life has to offer. We at Hyman, Phelps & McNamara, …
NDA approval – that pinnacle of drug development – marks a moment of success for both FDA and the drug applicant. The regulated and the regulator, having worked together for years, place a novel or improved therapy, with adequate directions for its use, in the …
In October, FDA issued a draft guidance titled “Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act,” which will replace a similar April 2011 draft guidance once finalized. This new draft guidance reflects a significant expansion of FDA’s …
With a little over a year under FDA’s belt implementing its Comprehensive Regenerative Medicine Policy Framework (which we blogged about here), CBER has updated its current thinking with the issuance of final versions of the two Regenerative Medicine Advanced Therapy (“RMAT”)-related guidance documents: Expedited Programs for …
A biotech company facing a complete response letter (CRL) action on its NDA/BLA has no greater goal than to quickly and fully understand the deficiencies that FDA has identified in the application. Such an understanding is critical to addressing the review division’s findings through additional …
In determining whether to submit a Formal Dispute Resolution Request (FDRR) appealing a Complete Response Letter (CRL) or other adverse action from FDA’s Office of New Drugs (OND), applicants necessarily consider how often such appeals are successful. The most cited relevant statistics were published by …
On November 16, 2017, FDA released a comprehensive policy framework for how the Agency intends to apply existing laws and regulations that govern regenerative medicine products, including human cells, tissues, and cellular and tissue-based products (HCT/Ps). The policy framework is set forth in a series …
On November 16, 2017, FDA released four guidance documents that, together, the Agency described as a “comprehensive policy framework” for applying existing laws and regulations governing regenerative medicine products, including human cells, tissues, and cellular and tissue-based products (“HCT/Ps”). The policy framework is set forth …
On July 11, 2017, the Government Accountability Office (GAO) provided Congress with an assessment report on FDA’s Expanded Access (“EA”) program. EA programs allow patients with serious or life-threatening diseases and no satisfactory therapy available to access investigational drugs outside of a clinical trial (report …
