The Lachman Blog

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28
Sep

Annual Report of 505(q) Petitions and Impact on the Delay of Associated Applications

  The FDA is required to produce a yearly report that addresses the number of petitions filed during the previous year, the number of those petitions that were designated as 505(q) petitions, and the number of the 505(q) petitions that delayed whether a 505(b)(2) application, ANDA or biosimilar approval. The FDA report (here) indicates that, […]

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17
Sep

FDA to Publish ALL Comments Submitted by Individuals to Dockets on Regulations.gov

Well, as someone who routinely reviews regulations.gov postings from the FDA, this comes as a bit of a surprise, because on some docket items there are literally thousands of comments to sift through.  Turns out that a pre-publication Federal Register notice (here) released today indicated that, back in 2007 when FDA merged its postings to […]

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