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1. Pathological complete response in neoadjuvant treatment of high-risk early-stage breast cancer: use as an endpoint to support accelerated approval

nlm:nlmuid-9918227256906676-pdf

2. Enforcement policy for viral transport media during the Coronavirus disease 2019 (COVID-19) public health emergency: guidance for commercial manufacturers, clinical laboratories, and Food and Drug Administration staff

nlm:nlmuid-9918227257306676-pdf

3. Regulatory considerations for human cells, tissues, and cellular and tissue-based products: minimal manipulation and homologous use : guidance for industry and Food and Drug Administration staff

nlm:nlmuid-9918227258706676-pdf

4. Cancer clinical trial eligibility criteria: minimum age considerations for inclusion of pediatric patients : guidance for industry and IRBs

nlm:nlmuid-9918227258806676-pdf

6. Cancer clinical trial eligibility criteria: patients with organ dysfunction or prior or concurrent malignancies

nlm:nlmuid-9918227259406676-pdf

7. Marketing status notifications under Section 506I of the Federal Food, Drug, and Cosmetic Act: content and format

nlm:nlmuid-9918227267606676-pdf

8. Enforcement priorities for electronic nicotine delivery systems (ENDS) and other deemed products on the market without premarket authorization (revised)

nlm:nlmuid-9918227268206676-pdf

9. Temporary policy regarding accredited third-party certification program onsite observation and certificate duration requirements during the COVID-19 public health emergency

nlm:nlmuid-9918227268506676-pdf

10. Temporary policy on repackaging or combining propofol drug products during the COVID-19 public health emergency

nlm:nlmuid-9918227268606676-pdf