USFDA's Guidance on Risk Management Plans to Mitigate Drug Shortages
USFDA's Guidance on Safety Considerations for Container Labels and Carton Labeling
Generic Drug User Fee Guidance - Assessing User Fees - USFDA
USFDA Guidance - Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
USFDA Guidance on Product Quality Assessments - Benefit-Risk Considerations
USFDA: Activities and Engagement with the Voluntary Improvement Program
USFDA Electronic Submission of IND Safety Reports - Technical Conformance Guide
USFDA Guidance on Electronic PostMarketing Safety Reporting
USFDA Guidance on “Pharm. Quality/CMC Data Exchange" and Drug Products containing Nanoparticles
FDA's Considerations for Waiver Requests for pH Adjusters in Generic Drug Products
FDA's Bioavailability Guidance for NDAs or INDs- General consideration
FDA's MAPP on Complex Product Classification for Generic Development
FDA Guidance:Providing Submissions in Electronic & Non-Elec Format—Promotional Labeling &Advertising
FDA's: OTC Monograph Drug User Fees for Fiscal Year 2022
USFDA Guidance on Verification Systems & Voluntary Recalls
USFDA: 3 updated Guidance on PLAIR, VQIP & Recalls
USFDA Guidance: Methods to Identify What Is Important to Patients
US FDA CDER Guidance Agenda -Calendar Year 2022
USFDA - Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs
USFDA Guidance on Premarket Review of Combination Products