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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Issue Date
Alternate Source of the Active Pharmaceutical Ingredient in Pending ANDAs: Guidance for Industry  Food and Drug Administration (FDA) Final
Alternative Procedures for Blood and Blood Components During the COVID-19 Public Health Emergency: Guidance for Industry  Food and Drug Administration (FDA) Final
Alternative to Certain Prescription Device Labeling Requirements : Guidance for Industry  Food and Drug Administration (FDA) Final
Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
An Acceptable Circular of Information for the Use of Human Blood and Blood Components: Guidance for Industry  Food and Drug Administration (FDA) Final
ANDA Submissions – Prior Approval Supplements Under GDUFA: Guidance for Industry  Food and Drug Administration (FDA) Final
ANDA Submissions — Amendments to Abbreviated New Drug Applications Under GDUFA: Guidance for Industry  Food and Drug Administration (FDA) Final
ANDA Submissions — Content and Format of Abbreviated New Drug Applications: Guidance for Industry  Food and Drug Administration (FDA) Final
ANDA Submissions — Refuse to Receive for Lack of Justification of Impurity Limits: Guidance for Industry  Food and Drug Administration (FDA) Final
ANDAs: Impurities in Drug Products: Guidance for Industry  Food and Drug Administration (FDA) Final
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