draft guidance

Comment Now! Rare Disease: Natural History Studies for Drug Development (FDA Draft Guidance)

4/11/2019

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The Food and Drug Administration (FDA) has released a draft guidance, “Rare Diseases: Natural History Studies for Drug Development”. We discussed another draft guidance released in January, “Rare Diseases: Common Issues in Drug Development” in our blog. The new draft guidance describes how natural history studies may be best used for drug development for rare diseases.

New Draft Q&A Guidance on RBM Released: Comment Now!

3/21/2019

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The Food and Drug Administration released a new draft guidance, “A Risk-Based Approach to Monitoring of Clinical Investigations: Questions and Answers Guidance for Industry”. The purpose of the guidance is to provide additional clarification to the finalized Risk Based Monitoring (RBM) guidance from 2013. Questions and answers provide details about:

Rare Diseases: Comment Period Now Open for Revised Draft (Update)

2/12/2019

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The Food and Drug Administration (FDA) has revised the draft guidance, “Rare Diseases: Common Issues in Drug Development Guidance for Industry”. The original draft guidance was issued August 2015. The revised draft guidance was published in the Federal Register February 1, 2019. Our previous blog mentioned that although it was available for public review January 16, there was a delay in publication and comment availability.

Rare Diseases: Comment Period Open Soon for Revised Draft

1/22/2019

The Food and Drug Administration (FDA) has revised the draft guidance, “Rare Diseases: Common Issues in Drug Development Guidance for Industry”. The original draft guidance was issued August 2015. The revised draft guidance is offered as an advance notice and will be published in the Federal Register at a later date.

FDA Announced Draft Guidance: Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank

10/31/2018

Background:

Currently, the “responsible party” must register and provide results of any applicable clinical trial in the ClinicalTrials.gov data bank under the requirements of the Food and Drug Administration Amendments Act (FDAAA) of 2007, which added the provision to the Public Health Service Act. Submitting false or misleading information, failing to register, or failing to provide results for applicable clinical trials is prohibited by an FDAAA amendment to the Federal Food, Drug, and Cosmetic Act (FD&C Act). Also, FDAAA amended 303(f)(3) of the FD&C Act to allow for assessment of civil money penalties for responsible parties who violated these provisions. This is relevant for drug, device, and biologic products.