Filed July 11, 2016
430, 21 C.F.R. § 20.61(a), or 21 C.F.R. § 20.61(b). Any such confidential information shall be marked as ‘HIGHLY CONFIDENTIAL – ATTORNEY’S EYES ONLY.
Filed July 14, 2016
Second, alerting the parties to FDA’s decision timetable would put it afoul of regulations governing confidentiality of ANDAs. See 21 U.S.C. § 331(j); 21 C.F.R. § 20.61; 21 C.F.R. § 314.430.
Filed November 18, 2014
Ranbaxy claims to have evidence that high-level FDA officials “were involved in establishing a line of precedent under which the Agency granted TAs for both of these ANDAs,” and that the agency purposefully granted the TAs despite full knowledge of the firm’s 11 FDA’s disclosure regulations limit the agency’s ability to disclose the details of those decisions. See 21 C.F.R. §§ 20.61, 314.430.
Filed October 23, 2009
at 4 (citing Joint Stock Soc’y v. UDV North Am., Inc., 104 F. Supp. 2d 390, 396 (D. Del. 2000), and United States v. Dentsply Int’l, Inc., 187 F.R.D. 152, 159 n. 6 (D. Del. 1999)). The Court also found the FDA Communications protectable pursuant to 21 C.F.R. § 20.61(b)-(c), which “exempt[s] privileged or confidential information submitted to the FDA from public disclosure.” Slip op.
Filed February 19, 2008
Additionally, FDA regulations provide that trade secrets and commercial information that is privileged or confidential are not available for public disclosure. 21 C.F.R. § 20.61. Exemption 6 of the FOIA permits the government to withhold all information about8 individuals in “personnel and medical files and similar files” when the disclosure of such information “would constitute a clearly unwarranted invasion of personal privacy.”
Filed November 15, 2007
. Second, because this case involves a challenge to an FDA decision4 on a drug application, there are prohibitions and limitations on FDA’s ability to disclose trade Case 1:07-cv-00668-JDB Document 32 Filed 11/15/2007 Page 4 of 6 See 21 U.S.C. 331(j); 18 U.S.C. § 1905; 21 C.F.R. § 20.61; 21 C.F.R. § 314.430.5 -5- secret and confidential information submitted by the drug sponsor with a drug application, and5 the parties would need to negotiate, and request that the Court enter, an appropriate protective order governing the handling and disclosure of such information belonging to Barr-Duramed. Accordingly, production of the administrative record should occur only after the Court determines that it has jurisdiction and that plaintiffs have alleged a viable cause of action.