Conversations in Drug Development Trends

FEBRUARY 21, 2024

To proactively manage subject expectations, we provide participants with the following: Dry restrooms No definitive stopping date Dietary requirements 24/7 collection of urine & fecal matter Blood sample collection 2. This process involves a careful assessment of medical history and daily bowel habits.

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FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

The draft guidance includes FAQs covering topics from across disciplines: regulatory review; chemistry, manufacturing, and controls (CMC); nonclinical and pharmacology/toxicology (PT); clinical; and clinical pharmacology.

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Agency IQ

DECEMBER 1, 2023

As before, the guidance provides recommendations on drug development for COVID-19 across five domains: population, trial design, efficacy endpoints, safety considerations and statistical considerations. On November 23, the FDA published a new, direct-to-final post-PHE version of the document.

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Agency IQ

DECEMBER 11, 2023

Older adults: While certain age-associated factors like comorbidities, age, and weight can be adjusted using standard clinical pharmacology methods; reviewers have noted that these factors do not entirely adjust for the differences we see in older patient populations.

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Agency IQ

FEBRUARY 12, 2024

Accelerated Approval of Drugs and Biologics Administrative/ Procedural New Civil Monetary Penalties for Failure to Meet Accelerated Post Marketing Requirements Administrative/ Procedural Carried over from previous guidance agenda Exclusivity for First Interchangeable Biosimilar Biological Products Administrative/ Procedural Carried over from previous (..)

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Agency IQ

FEBRUARY 15, 2024

These topics include administrative, advanced manufacturing, the Animal Rule, antimicrobials, biosimilars, blood products, breakthrough devices, cell and gene therapy products, CGMP, clinical pharmacology, clinical trials, clinical/medical guidance, combination products, communication, compounding, cybersecurity, device software, digital health technologies, (..)

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Agency IQ

DECEMBER 1, 2023

January 2024 Amendments to Patent Term Restoration (Proposed Rule) FDA is proposing to amend its Patent Term Restoration regulations to identify the effective date of approval for scheduled drugs, to define when the 60-day period referred to in 35 U.S.C. fit in this definition.

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