"Guidance for Industry: For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture and for the Completion of the Form FDA 356h, 'Application to Market a New Drug, ...
FDA Issues New Form FDA 3926 and Final Guidance for Its Use, a New Approach for Physicians to Request FDA Approval for Expanded Access to Investigational Drugs for Individual PatientsRogers, Daniel R
When You Don't Need a Form 3674; FDA Is Asked for Guidance on Design of Pneumonia Trials; IRB Blocked from Granting Expedited Approvals; PhRMA Objects to Characterization of All Industry-Sponsored Clinical Trials as Biased; Protections for Subjects in Overseas Trials; Questionable Cell Therapy ...
FDA issues draft guidance regarding the incorporation of physical-chemical identifiers into solid oral dosage form drug products for anticounterfeiting.Ball, Frederick
FDA Releases Draft Guidance on Drug and Device Manufacturer Communication of Health Care Economic Information to Payors, Formulary Committees and Similar Entities Under FDAMA 114Daniel A. Kracov
IRS Releases Transitional Guidance on Delays for Information Reporting and Employer MandateBy Rich Gisonny