USA
Showing 1–16 of 20 results
-
FDA : Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) (2020)
$0.00 Add to cart -
FDA : Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
$3.00 Add to cart -
FDA Guidance : Acceptance and Filing Review for PMAs
$5.00 Add to cart -
FDA Guidance: 510(k)-Review-Program (2020)
$0.00 Add to cart -
FDA Guidance: ANDA Submissions —Content and Format (2018)
$0.00 Add to cart -
FDA Guidance: Annual Reports for Approved Premarket Approval Applications (PMA) (2019)
$2.00 Add to cart -
FDA Guidance: Bioavailability Studies Submitted in NDAs or INDs — General Considerations (2019)
$2.00 Add to cart -
FDA Guidance: Cosmetic Good Manufacturing Practices (2013)
$0.00 Add to cart -
FDA Guidance: Data Integrity and Compliance With Drug CGMP Questions and Answers
$0.00 Add to cart -
FDA Guidance: Expedited Programs for Serious Conditions – Drugs and Biologics
$2.00 Add to cart -
FDA Guidance: Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA
$0.00 Add to cart -
FDA Guidance: Investigational New Drug Applications (INDs) —Determining Whether Human Research Studies Can Be Conducted Without an IND
$0.00 Add to cart -
FDA Guidance: Providing Regulatory Submissions for Medical Devices in Electronic Format (2020)
$0.00 Add to cart -
FDA Guidance: Referencing Approved Drug Products in ANDA Submissions
$0.00 Add to cart -
FDA Guidance: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
$0.00 Add to cart -
FDA Guidance: Safety of Nanomaterials in Cosmetic Products
$0.00 Add to cart