Recently Posted Guidance Documents on Drugs, ICH-Multidisciplinary, Clinical Trials, Premarket, and Radiological Health

10/5/2017 CVM GFI #236 Clarification of FDA and EPA Jurisdiction Over Mosquito-Related Products 10/4/2017 Completeness Assessments for Type II API DMFs Under GDUFA Guidance for Industry 10/4/2017 ANDA Submissions – Prior Approval Supplements Under GDUFA 10/3/2017  Individual Patient Expanded Access Applications: Form FDA 3926 10/3/2017 Expanded Access to Investigational Drugs for Treatment Use — Qs & As 10/2/2017 ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin Guidance for Industry 10/2/201  ANDA Submissions — Amendments to Abbreviated New Drug Applications Under GDUFA Guidance for Industry 10/2/2017 Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA Guidance for Industry 10/2/2017 ANDA Submissions - Refuse-to-Receive Standards: : Questions and Answers Guidance for Industry ICH-Multidisciplinary 10/3/2017 M4 Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use Guidance for Industry Clinical Trials/GCP 10/3/2017 Waiver of IRB Requirements for Drug and Biological Product Studies - Information Sheet Premarket 10/2/2017  FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals - Guidance for Industry and Food and Drug Administration Staff 10/2/2017 User Fees and Refunds for Premarket Notification Submissions (510(k)s) - Guidance for Industry and Food and Drug Administration Staff 10/2/2017 User Fees for 513(g) Requests for Information - Guidance for Industry and Food and Drug Administration Staff 10/2/2017 Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff - Guidance for Industry and Food and Drug Administration Staff 10/2/2017 FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals - Guidance for Industry and Food and Drug Administration Staff 10/2/2017 User Fees and Refunds for De Novo Classification Requests - Guidance for Industry and Food and Drug Administration Staff 10/2/2017 User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications - Guidance for Industry and Food and Drug Administration Staff 10/2/2017 Marketing Clearance of Diagnostic Ultrasound Systems and Transducers - Draft Guidance for Industry and Food and Drug Administration Staff 10/2/2017  FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals - Guidance for Industry and Food and Drug Administration Staff Radiological Health 10/2/2017 Classification and Requirements for Laser Illuminated Projectors (LIPs) (Laser Notice No. 57) - Draft Guidance for Industry and Food and Drug Administration Staff