Sep 06 2018

New FDA Guidances for August 2018

By Michelle Villasmil, Ph.D., RAC (US), Regulatory Scientist II at Cato Research


FDA draft and final guidances released from CDER, CBER, and CDRH in August are posted. In addition, upcoming advisory committee meetings are listed below with links to more information.


Special Interest Guidances/Information Date Posted
Hematologic Malignancy and Oncologic Disease: Considerations for Use of Placebos and Blinding in Randomized Controlled Clinical Trials for Drug Product Development– Draft Guidance 23 Aug 2018
Osteoarthritis: Structural Endpoints for the Development of Drugs – Draft Guidance 22 Aug 2018
Quality Attribute Considerations for Chewable Tablets – Final Guidance 20 Aug 2018
Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations – Final Guidance 20 Aug 2018
Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices – Draft Guidance 17 Aug 2018
Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics – Draft Guidance 10 Aug 2018
Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances – Final Guidance 08 Aug 2018
Elemental Impurities in Drug Products – Final Guidance 07 Aug 2018
Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment – Draft Guidance 06 Aug 2018
Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products – Draft Guidance 03 Aug 2018
Medical Device User Fee Small Business Qualification and Certification – Final Guidance 01 Aug 2018
Upcoming Meetings (* = New)
* September 12, 2018: Meeting of the Pharmacy Compounding Advisory Committee
September 20, 2018: Meeting of the Pharmaceutical Science and Clinical Pharmacology Advisory Committee
* September 20, 2018: Pediatric Advisory Committee Meeting
* September 27, 2018: Neurological Devices Panel of the Medical Devices Advisory Committee
* October 3, 2018: Vaccines and Related Biological Products Advisory Committee
Last updated: 05 September 2018