Source: http://www.fdalawblog.net/page/243/
Timestamp: 2020-08-05 17:00:25
Document Index: 19504890

Matched Legal Cases: ['§ 505', '§ 909', '§ 314', '§ 601', '§ 505', '§ 351', '§ 505', '§ 505', '§ 351', '§ 351', '§ 505', '§ 505', '§ 351']

FDAAA was signed into law on September 27, 2007. Title IX, Subtitle A of FDAAA created new FDC Act § 505-1, which authorizes FDA to require applicants submitting a marketing application for a prescription drug or biological product to submit and implement a REMS if the Agency determines that such a mechanism is necessary to ensure that the benefits of the product outweigh its risks. Certain products approved prior to the effective date of FDAAA are, under FDAAA § 909(b)(1), deemed to have a REMS in effect “if there are in effect on the effective date of this Act elements to assure safe use — (A) required under [FDA’s accelerated approval restricted distribution regulations at 21 C.F.R. § 314.520 or § 601.42]; or (B) otherwise agreed to by the applicant and the Secretary [of Health and Human Services] for such drug.” New FDC Act § 505-1(f)(3) states that “elements to ensure safe use” include the following:
New to H.R. 5629 is a provision stating that an application for a biological product must be submitted under PHS Act § 351, except that “an application for a biological product may be submitted under [FDC Act § 505] if – (A) such biological product is in a product class for which a biological product in such product class is the subject of an application approved under [FDC Act § 505] not later than the enactment of [the Pathway for Biosimilars Act]; and (B) such application” was submitted to FDA before the enactment of the Pathway for Biosimilars Act or is submitted to FDA not later than 10 years after enactment. This exception provision is limited so that “if there is another biological product approved under [PHS Act § 351(a)] that could be a reference product with respect to such application” (that is, if such application were submitted under new PHS Act § 351(k) for a biosimilar), then the application may not be submitted under FDC Act § 505. If enacted, H.R. 5629 would also deem an application for a biological product approved under FDC Act § 505 to be a license under PHS Act § 351 on the date that is 10 years after the enactment of the Pathway for Biosimilars Act.
It’s a Bird, It’s a Plane, It’s a Super-Lawyer! (Actually, 4 of Them!)
Hyman, Phelps & McNamara, P.C. (“HPM”) is happy to announce that 4 of the firm’s attorneys have been named Super Lawyers in the Washington, D.C., area. The March 2008 edition of Washington, D.C. Super Lawyers identifies 17 Super Lawyers from the Food and Drug Bar. HPM snagged 4 of the slots – more than any other firm! Congrats go to HPM’s James R. Phelps, Paul M. Hyman, Robert A. Dormer, and Douglas B. Farquhar.
FDA Announces that Dr. Janet Woodcock Will Reprise Role as CDER Director
Earlier today, FDA announced that Dr. Janet Woodcock was appointed as the permanent director of FDA’s Center for Drug Evaluation and Research (“CDER”). The CDER directorship is a position familiar to Dr. Woodcock. She served as CDER Director from 1994 to 2005. Dr. Woodcock’s most recent position at FDA was as the Agency’s Chief Medical Officer and Deputy Commissioner. She also served as Acting CDER Director since October 2007. Over the past several years Dr. Woodcock played a leading role in FDA’s “Critical Path” Initiative, which is designed to improve the scientific basis for medical product development, and spearheaded the Agency’s pharmacogenomics initiative, among other things.
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