> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Latest Federal Register Notices
- URL: https://www.fdaweb.com/latest-federal-register-notices-223/
- Published: 2019-05-12T12:00:00.000Z
- Updated: 2026-09-15T01:26:09.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5144093

[**Guide on Submitting ANDA or 505(b)(2) NDA**](https://www.fdaweb.com/guide-on-submitting-anda-or-505-b-2-nda/)  
*Federal Register* notice: FDA makes available a guidance entitled “Determining Whether to Submit an ANDA or a 505(b)(2) Application.” 05/10/2019

[**Topical Active Ingredients for OTC Monograph Guide**](https://www.fdaweb.com/topical-active-ingredients-for-otc-monograph-guide/)  
*Federal Register* notice: FDA makes available a final guidance entitled “Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations.” 05/10/2019

[**Guide on Oncology Drug Reproductive Toxicity Testing**](https://www.fdaweb.com/guide-on-oncology-drug-reproductive-toxicity-testing/)  
*Federal Register* notice: FDA makes available a final guidance entitled “Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations.” 05/10/2019

[**Draft Guide on Real World Data Submissions**](https://www.fdaweb.com/draft-guide-on-real-world-data-submissions/)  
*Federal Register* notice: FDA makes available a draft guidance entitled “Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics.” 05/09/2019  
  
[**Pregnancy Safety Studies Draft Guide**](https://www.fdaweb.com/pregnancy-safety-studies-draft-guide/)  
*Federal Register* notice: FDA makes available a draft guidance entitled “Postapproval Pregnancy Safety Studies” that provides recommendations on how to design investigations to assess the outcomes of pregnancies in women exposed to drugs/biologics. 05/09/2019

[**Draft Guide on Lactation Study Designs**](https://www.fdaweb.com/draft-guide-on-lactation-study-designs/)  
*Federal Register* notice: FDA makes available a draft guidance entitled “Clinical Lactation Studies: Considerations for Study Design.” 05/09/2019

[**New DTC Study on Accelerated Approval Disclosures**](https://www.fdaweb.com/new-dtc-study-on-accelerated-approval-disclosures/)  
*Federal Register* notice: FDA submits to OMB a new information collection entitled “Experimental Study of an Accelerated Approval Disclosure.” 05/08/2019