NLM Digital Collections

Search

Search Constraints

Start Over You searched for: Copyright Public domain Remove constraint Copyright: Public domain Dates by Range 2000 and later Remove constraint Dates by Range: 2000 and later

Search Results

1831. Recommended content and format of non-clinical bench performance testing information in premarket submissions: guidance for industry and Food and Drug Administration staff

1832. Hematologic malignancies: regulatory considerations for use of minimal residual disease in development of drug and biological products for treatment

1833. REMS: FDA's application of statutory factors in determining when a REMS is necessary

1834. Extending expiration dates of doxycycline tablets and capsules in strategic stockpiles: guidance for government public health and emergency response stakeholders

1835. Class II special controls guideline: in vitro diagnostic devices for Bacillus spp. detection : guideline for industry and Food and Drug Administration staff

1836. 30-Day notices, 135-day premarket approval (PMA) supplements and 75-day humanitarian device exemption (HDE) supplements for manufacturing method or process changes: guidance for industry and Food and Drug Administration staff

1837. Unique device identification: convenience kits : guidance for industry and Food and Drug Administration staff

1838. Requests for feedback and meetings for medical device submissions: the Q-Submission Program : guidance for industry and Food and Drug Administration staff

1839. Utilizing animal studies to evaluate organ preservation devices: guidance for industry and Food and Drug Administration staff

1840. Medical x-ray imaging devices conformance: guidance for industry and Food and Drug Administration staff