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21 C.F.R. § 20.61

Section 20.61 - Trade secrets and commercial or financial information which is privileged or confidential
Section 20.61 - Trade secrets and commercial or financial information which is privileged or confidential

6 Citing briefs

  1. Astrazeneca Pharmaceuticals LP v. Burwell et al

    MEMORANDUM re Scheduling Order

    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.

  2. Astrazeneca Pharmaceuticals LP v. Burwell et al

    RESPONSE re MOTION to Modify Court's Order

    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.

  3. Ranbaxy Laboratories, LTD et al v. Burwell et al

    Memorandum in opposition to re MOTION for Temporary Restraining Order

    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.

  4. Pennsylvania Employee Benefit Trust Fund v. Zeneca Inc. et al

    MEMORANDUM in Support re MOTION to Seal Unredacted Plaintiffs' Answering Brief in Opposition to Defendants' Motion to Dismiss

    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.

  5. Government Accountability Project v. U.S. Department of Health and Human Services

    MOTION to Stay

    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.”

  6. Association of American Physicians and Surgeons, Inc. et al v. Food and Drug Administration et al

    Memorandum in opposition to re MOTION to Compel Federal Defendants to Certify Administrative Record

    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.