Fda guidance for industry hiv

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Important Email Policy | FDA

The secondary contact email can be a group or generic or individual email. For any questions/concerns relating to email policy, please contact …


Revised Recommendations for Reducing the Risk of …

1 . Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by . Blood and Blood Products . Guidance for Industry


Cancer Clinical Trial Eligibility Criteria: Patients with

Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus Infections Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document should be submitted within 60 days of


WHO welcomes FDA approval of new formulation of

Jun 18, 2020 · WHO welcomes the recent decision by the U.S. Food and Drug Administration (FDA) to approve a dispersible 5 mg formulation of dolutegravir (DTG) for use in infants and children living with human immunodeficiency virus type 1 (HIV-1). The tablet, taken orally, has been approved for use in paediatric patients from four weeks of age weighing at least 3 kg in …


Infectious Disease Next Generation - cacmap.fda.gov

Draft Guidance for Industry and . 111. Food and Drug Administration Staff . 112 113. This draft guidance, when finalized, will represent the current thinking of the Food and . 114. Drug Administration (FDA or Agency) on this topic. It does not establish any rights for . 115. any person and is not binding on FDA or the public. You can use an


Study Data Standards Resources | FDA

Nov 19, 2021 · Electronic Source Data in Clinical Investigations: Guidance for Industry (PDF - 52KB) (Sept. 2013) - This non-binding guidance provides recommendations to sponsors, contract research organizations (CROs), clinical investigators, and others involved in the capture, review, and retention of electronic source data in FDA-regulated clinical


FDA.COM Information Portal

On-Line Discussion Groups and Information Portal serving the Pharmaceutical, Biotechnolgy, Medical Device, Food and Cosmetic Regulated Industry by Industry Professionals. FDA.COM is the next step for professionals seeking compliance information through discussion groups and on-line information sharing. Directed by John Cuspilich, Director Regulatory Affairs and Michael …


OIVD Guidance Documents

Mar 12, 2014 · OIVD. 1706. 11/06/2009. (4) Guidance for Industry and FDA Staff: Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices. OIVD. 1171. 01/30/2008. (5) Guidance for Industry and FDA Staff - Assayed and Unassayed Quality Control Material.


Compliance Actions (Biologics) | FDA

Sep 15, 2021 · Office of Communication, Outreach and Development. Center for Biologics Evaluation and Research. Food and Drug Administration. 10903 New Hampshire Ave WO71-3103. Silver Spring, MD 20993-0002. [email protected] (800) 835-4709. (240) 402-8010. For Updates on Twitter, follow @fdacber.