Biosimilars regulations unlikely to unfold soon

February 2011
Drug Store News;2/7/2011, Vol. 33 Issue 2, p28
Trade Publication
The article reports on the repeal of the Patient Protection and Affordable Care Act by the U.S. Congress. It notes that the effort largely is unlikely to succeed, so at least one portion of the healthcare-reform law will remain in effect. Furthermore, it mentions that the Food and Drug Administration (FDA) has sponsored a public meeting to collect input from interested parties about what form regulations for follow-on biologics will take.


Related Articles

  • By Creating Impassable Pathway, Biosimilar Law Could be DOA. Thiel, Karl // BioWorld Today;6/1/2010, Vol. 21 Issue 104, p1 

    The article analyzes the biosimilar provisions within the Patient Protection and Affordable Care Act. Cited in the bill are suggestions about what the U.S. Food and Drug Administration (FDA) may or may not request in terms of evidence of similarity but almost all of it depends on the judgment of...

  • (CONGRESS) Advocates Urge Protections in Final Health Reform Bill. Byrne, James // Community Health Funding Week;1/15/2010, p13 

    The article focuses on the healthcare reform bills passed in both houses of the U.S. Congress. The bills include the U.S. House-passed Affordable Health Care for America Act and the U.S. Senate's Patient Protection & Affordable Care bill. The National Association of Community Health Centers...

  • FDA bill nears finish line in both House and Senate. Baker, Sam // Hill;5/14/2012, Vol. 19 Issue 59, p16 

    The article reports that the major Food and Drug Administration (FDA) bill was nearly to be completed by the U.S. Congress in a rare moment of bipartisanship on healthcare policy.

  • Obama's health care quest become a parody of leadership. Samuelson, Robert J. // Fort Worth Business Press;12/28/2009, Vol. 25 Issue 49, p26 

    The author offers his opinion on the legislative proposals of U.S. President Barack Obama for the country's health care sector. According to the author, Obama is supporting an unpopular legislation that becomes a threat to the country's long-term interests. He believes that even if Congress...

  • Business Roundtable Statement on House Energy and Commerce Committee Action on Medical Liability.  // Biomedical Market Newsletter;5/15/2011, p226 

    The article focuses on the statement of Business Roundtable on House Energy and Commerce Committee for advancing the House Resolution (H.R.), the Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act. It says that the access to care while ensuring the protection of individuals who...

  • PDUFA Hits Small Speed Bump in House Subcommittee. Serebrov, Mari // BioWorld Today;4/27/2012, Vol. 23 Issue 82, p1 

    The article reports on the postponement by the U.S. House Energy and Commerce Subcommittee on the markup of its version of the Prescription Drug User Fee Act (PDUFA). According to the subcommittee, there is a need to reach a comprehensive agreement on the user fee bill prior to the markup. It...

  • Senate HELP gets first look at FDA Mission Reform Act. McCarty, Mark // Medical Device Daily;12/13/2011, Vol. 15 Issue 237, p1 

    This article reports on the introduction of the U.S. Food and Drug Administration Mission Reform Act of 2011 to the Senate Health, Education, Labor and Pensions Committee (HELP) in December 2011. According to Senator Dan Coats, one feature of the bill is the addition of the phrase "least...

  • US science faces big chill. Semeniuk, Ivan; Wadman, Meredith; Samuel Reich, Eugenie; Tollefson, Jeff // Nature;1/6/2011, Vol. 469 Issue 7328, p9 

    The article focuses on the bills and legislation in the U.S. related to science and technology, and on its funding aspects. It states that the U.S. Congress has reauthorized the America COMPETES Act, the authorization of a bill that will give the U.S. Food and Drug Administration (FDA) power to...

  • Congress vouches for priority review of childhood disease. Palmer, Roxanne // Nature Medicine;Feb2012, Vol. 18 Issue 2, p181 

    The article focuses on the introduced legislation of the U.S. Congress, the priority review vouchers (PRV), which aims in improving development of treatments for rare pediatric diseases. The PRV voucher program was originally offered by the Food and Drug Administration. Several critics,...


Read the Article


Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics