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Overview and analysis of the proposed federal sunshine
- Reed Smith LLP
- -
- USA
- -
- January 30 2012
On December 19, 2011, the Centers for Medicare & Medicaid Services published a proposed rule related to section 6002 of the Affordable Care Act, commonly referred to as the “Physician Payment Sunshine Act”
FDA issues final rule on sterility testing of biological products
- Reed Smith LLP
- -
- USA
- -
- May 11 2012
On May 3, 2012 the FDA issued its final rule on sterility testing, amending the requirements for most licensed biological products effective June 4, 2012
FDA issues guidance document on drug pedigree issues
- Reed Smith LLP
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- USA
- -
- March 31 2010
FDA issued the first in a series of guidance documents intended to bolster the security of the nation's drug supply
FDA transparency meeting
- Reed Smith LLP
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- USA
- -
- June 3 2009
The FDA is holding a meeting June 24, 2009 to solicit recommendations on ways the agency can make useful and understandable information about FDA activities and decision making more readily available to the public
Current good manufacturing practice requirements for combination products
- Reed Smith LLP
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- USA
- -
- September 23 2009
On September 23, 2009, the FDA published a proposed rule to codify current good manufacturing practice (cGMP) requirements that apply when drugs, devices, and biological products are combined to create a combination product
FDA guidance documents
- Reed Smith LLP
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- USA
- -
- September 23 2009
The FDA is accepting comments on the following new draft guidance documents for industry
Promotion of medical products using the Internet and social media
- Reed Smith LLP
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- USA
- -
- September 23 2009
The FDA is seeking public input on the promotion of FDA-regulated medical products (including prescription drugs and biologics and medical devices) using the internet and social media tools (e.g., blogs, microblogs, podcasts, social networks and online communities, video sharing, widgets, and wikis
Dietary supplements
- Reed Smith LLP
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- USA
- -
- March 6 2009
The Government Accountability Office (GAO) has issued a report entitled "Dietary Supplements: FDA Should Take Further Actions to Improve Oversight and Consumer Understanding."
New law allows FDA to regulate tobacco products
- Reed Smith LLP
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- USA
- -
- June 24 2009
On June 22, 2009, President Obama signed into law H.R. 1256, the “Family Smoking Prevention and Tobacco Control Act,” as amended
FDA postmarketing safety reporting for combination products
- Reed Smith LLP
- -
- USA
- -
- October 15 2009
On October 1, 2009, the Food and Drug Administration (FDA) published a proposed rule clarifying postmarketing safety reporting requirements that apply when regulated products (drugs, devices, and biological products) are combined to create a combination product
Current Search
- Jurisdiction - USA
- Workarea - Product Liability
- Author - Debra A. McCurdy