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…ones. . . .” (see here and here) GAO Report In its Report, the GAO confirmed much of what on-lookers, industry, and FDA already knew or suspected. The Report cites…
…Modernization Act (“FSMA”). The fees kick in on October 1, 2011. The hourly fee rate is $224 ($335 if foreign travel is required). FDA can be expected to collect fees…
By Karla L. Palmer FDA published for comment two non-binding draft guidance documents addressing compounding of commercially available drug products by traditional pharmacies under FDCA Section 503A and outsourcing facilities…
…and reporting suspicious orders (e.g., DEA’s Distributors’ Conferences) and plans for additional yearly distributor training. DEA “did not mention” plans to develop and distribute additional guidance for distributors. GAO believes…
…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…
…for an individually identified patient. Section 503A has always permitted compounders to compound copies of shortage medications (which are not, by definition, “essential copies” of commercially available drug products). Never…
…v. Brown, No. 2:17-cv-02573 (E.D. Cal. Jan. 26, 2018) (quoting Friends of the Earth, Inc. v. Laidlaw Envtl. Servs., Inc., 528 U.S. 167, 181 (2000)). The court held that PhRMA’s…
…. . . On March 14, 2017, FDA filed with the DC Circuit an Unopposed Motion for Voluntary Dismissal. The DC Circuit dismissed the case in a March 17, 2017…
…1998 U.S. – E.U. Mutual Recognition Agreement, with a view to avoiding duplicative inspections and saving millions of dollars in repetitive inspections. FDA has stated that they believe this “…initiative…
…to equal protection and due process.” That argument failed. Next, the defendant contended that “people of ordinary intelligence cannot understand what 21 U.S.C. § 352 means.” The prohibition on distribution…
…in the final decision.” U.S. Dept. of Justice, Attorney General’s Manual on the Administrative Procedure Act 80 (1947) (Wm. W. Gaunt & Sons, Inc., Reprint 1979). In accordance with the…
…been mulling CDSS guidance for the past few years. However, it has never issued draft guidance. The closest FDA has come is the Mobile Medical Apps guidance (Feb. 2015), which…
…the Agency received numerous comments from industry and Congress. These positions include: “Grandfathered” ingredients. The Agency narrowly construes the category of “grandfathered” (or “old”) dietary ingredients, i.e., those that are…
…other, legitimate purposes (see, e.g., United States v. Borrasi, 639 F.3d 774 (7th Cir. 2011), here, and United States v. Greber, 760 F.2d 68, 71 (3d Cir.), cert. denied, 474…
…the Supreme Court. See Brief for the Federal Respondents, State of California, et al. v. State of Texas, et al., Nos. 19-840 and 19-1019. If the suit is successful, this…