USFDA Update: In-Person, Face-to-Face ANDA Program Meetings
USFDA Guidance: General Considerations for Animal Studies Intended to Evaluate Medical Devices
USFDA MD Guidance: Transition Plan for M.D Issued Emergency Use Authorizations Related to COVID-19
USFDA Guidance: Clinical Trial Considerations to Support Accelerated Approval of Oncology Products
USFDA Guidance: Pharmacogenomic Data Submissions
USFDA Guidance: Electronic Systems, e-Records, & e-Signatures in clinical Investigations: Q&A
USFDA Guidance: CMC-Potency Assay Considerations for Monoclonal Antibodies & Therap. Protiens
ICH-Quality Guidance: Q13 Continuous Manufacturing of Drug Substances and Drug Products
USFDA Med. Device: Guidance on Laser Products, Diagnostics, X-ray & Ultrasonic Diathermy Devices
USFDA Guidance: Product-Specific Guidance Meetings Between FDA and ANDA Applicants
ICH (USFDA) Guidance: Bioequivalence for Immediate-Release Solid Oral Dosage Forms
USFDA Guidance: Design and Conduct of Externally Controlled Trials for Drug and Biological Products
USFDA Guidance: Content & Format - Dosage and Administration Section of Labeling
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USFDA Guidance: Photobiomodulation (PBM) Devices & Premarket Notification [510(k)] Submissions
USFDA Guidance: Finalized REMS Format, Content and Technical Conformance Guide
USFDA Guidance: Controlled Correspondence Related to Generic Drug Development
USFDA Guidance: Failure to Respond to an ANDA Complete Response Letter
USFDA ME Guidance: Voluntary Malfunction Summary Reporting (VMSR) Program
USFDA Guidance: Homeopathic Drugs Products
USFDA Guidance: Selective Approach to Safety Data Collection & Dosing Regimens of PD1 & PD-L1