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News and Press: Policy News

Slew of FDA-Related Bills Introduced in Congress

Thursday, May 28, 2015   (0 Comments)
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Numerous legislators decided to introduce stand-alone bills, either breaking out provisions from the 21st Century Cures Act, or seeking consideration of legislation addressing new FDA-related topics. Here’s a list of those bills with a brief descriptions:

H.R. 2459

To amend the Federal Food, Drug, and Cosmetic Act to enhance the reporting requirements pertaining to use of antimicrobial drugs in food animals

H.R. 2455

To amend the Federal Food, Drug, and Cosmetic Act with respect to precision medicine

H.R. 2452

To amend the Federal Food, Drug, and Cosmetic Act with respect to facilitating dissemination of health care economic information

H.R. 2444

To authorize the Commissioner of Food and Drugs to award grants for studying the process of continuous drug manufacturing

H.R. 2443

To amend the Federal Food, Drug, and Cosmetic Act with respect to CLIA waiver study design guidance for in vitro diagnostics

H.R. 2438

To amend the Federal Food, Drug, and Cosmetic Act with respect to broader application of Bayesian statistics and adaptive trial designs

H.R. 2435

To amend the Federal Food, Drug, and Cosmetic Act with regard to the Reagan-Udall Foundation

H.R. 2433

To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review

H.R. 2428

To amend the Federal Food, Drug, and Cosmetic Act with respect to humanitarian device exemption applications

H.R. 2427

To amend the Federal Food, Drug, and Cosmetic Act with respect to advisory committee process

H.R. 2426

To amend the Federal Food, Drug, and Cosmetic Act with respect to easing regulatory burden with respect to certain class I and class II devices

H.R. 2425

To amend the Federal Food, Drug, and Cosmetic Act with respect to the recognition of standards

H.R. 2424

To amend the Federal Food, Drug, and Cosmetic Act with respect to training and oversight in least burdensome appropriate means concept

H.R. 2423

To amend the Federal Food, Drug, and Cosmetic Act with respect to valid scientific evidence

 

H.R. 2422

To amend the Federal Food, Drug, and Cosmetic Act with respect to third-party quality system assessment

H.R. 2416

To amend the Federal Food, Drug, and Cosmetic Act to evaluate the potential use of evidence from clinical experience to help support the approval of new indications for approved drugs, and for other purposes

H.R. 2415

To amend the Federal Food, Drug, and Cosmetic Act to provide for establishment of a streamlined data review program

Introductions of the above bills follows others submitted in May including the Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act (H.R. 2396), the Stop Tampering of Prescription Pills Act of 2013 (H.R. 2335), legislation to authorize priority review for breakthrough devices (H.R. 2337), and legislation to provide for the development and use of patient experience data to enhance the structured risk-benefit assessment framework (H.R. 2338).


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