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…requesting reconsideration of a CR amendment, the applicant will submit a written request for a post-CR-letter meeting within 10 business days from issuance of the CR letter. . . . …
…before FDA is funded for Fiscal Year 2012. Several Senate amendments to H.R. 2112 were considered and rejected, including Sen. David Vitter’s (R-LA) Amendment No. 769 to permit individuals to…
…2 approvals in January. REMINDER: HP&M is hosting FDA Appeals – Improving Your Odds of Success: Trends, Expectations, Strategies, a webinar on March 21, 2012, 12:30 – 2:00 p.m. ET. Click here to register….
…regulatory issues and questions. Under the Food and Drug Administration Reauthorization Act and the MDUFA IV Commitment Letter, certain changes were made to the Pre-Submission program. Most of these were…
…do in individuals without these disorders. At times, there has been speculation that these can be actual “cures,” and at some point, they might well be. However, there are many…
…are . . . well . . . destructive. They may exist on another Earth in the Multiverse, but bringing them into our “Exclusivity Earth-616” would result in an incursion….
…standard). With the approach of the January 1, 2022 mandatory compliance deadline for the BE standard, manufacturers and importers of food and dietary supplements should work to develop strategies for…
…hiccups in the system that should be addressed. Refunds often take years to process: maybe it is time to ask for some time commitments for review of refund requests? Or…
…about added sugar labeling, etc., the compliance date was extended to Jan. 1, 2020. Although this could have been enough time to revise labels, the timing of pertinent FDA guidance,…
…case was vacated on appeal on joint motion of the party. United States v. Franck’s Lab, Inc., No. 11-15350, 2012 U.S. App. LEXIS 27100 (11th Cir. Oct. 18, 2012). It…
…depicting the negative health consequences of smoking to accompany the label statements . . . .” Even though FDA pointed to its original compliance with the two year deadline before…
…e.g., here and here). While this approach has allowed DEA to avoid the notice and comment rulemaking requirement under the Administrative Procedure Act (“APA”), it has also left industry with…
…nomination process. The next 90 days will be fascinating to watch as outsourcing facilities comment on FDA’s proposed process, which comments are due on May 25, 2018 (Docket No. FDA-2018-D-1067)….
…pose risks. The proposed rule also establishes a timeframe by which food articles subject to refusals or holds must become compliant. In some cases, foods imported without a prior notice,…
…F. Supp. 443 (D. Del. 1997); Bristol-Myers Squibb Co. v. Shalala, 923 F. Supp. 212 (D.D.C. 1996); Fisons Corp. v. Shalala, 860 F. Supp. 859 (D.D.C. 1994). Interestingly, FDA has…