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FDA's Draft Guidance on Cybersecurity in MD: Quality System Consideration & Content of Premarket Sub
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
USFDA - Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs
USFDA Guidance on Premarket Review of Combination Products
Guidance on Revising ANDA Labeling Following Revision of the RLD Labeling
Patients’ Experiences & Engagements Medical Device Guidances - USFDA
USFDA Guidance update on Generic Drug Application Submissions, Labeling, and Review
First Oral Antiviral (PFIZER) for Treatment of COVID-19 -USFDA
Unannounced Inspections in India And China to be Resumed Soon: USFDA
Guidance for Residual Solvents: Q3C(R8) Impurities