Tag Archive: FDA

Nov 06

New FDA Guidances for October 2018

By Joanne McNelis, Ph.D., RAC (US), Clinical Strategy Scientist II at Cato Research FDA draft and final guidances released from CDER, CBER, and CDRH in October are posted. In addition, upcoming advisory committee meetings are listed below with links to more information.   Special Interest Guidances/Information Date Posted Considerations for the Development of Dried Plasma …

Continue reading »

Oct 02

New FDA Guidances for September 2018

By Zachary Swan, Ph.D., Regulatory Scientist at Cato Research FDA draft and final guidances released from CDER, CBER, and CDRH in September are posted. In addition, upcoming advisory committee meetings are listed below with links to more information.   Special Interest Guidances/Information Date Posted Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the …

Continue reading »

Sep 06

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 …

Continue reading »

Aug 16

New FDA Guidances for June and July 2018

By Joanne McNelis, PhD, RAC (US), Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH, in April are posted. In addition, upcoming advisory committee meetings are listed below with links to more information.   Special Interest Guidances/Information Date Posted Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis; Draft Guidance …

Continue reading »

Jul 12

FDA Approval of Epidiolex and the Cannabis-Based Drug Pipeline

By: Kristen Biernat, Cato Research   The Food and Drug Administration (FDA) granted approval of the cannabis-based drug Epidiolex to GW Research Ltd. (GW) on June 25, 2018.1 The FDA’s approval of Epidiolex represents two major milestones for GW: First, it is addresses the unmet need for patients with Lennox-Gastaut syndrome and Dravet syndrome, two …

Continue reading »

Jun 13

2018 Changes in the User Fee Program for Prescription Drugs Under PDUFA VI

By Juliati Rahajeng, Ph.D., Scientist at Cato Research   The Food and Drug Administration Reauthorization Act (FDARA) was signed into law by the President on August 18, 2017. The law comprises the reauthorization of the Prescription Drug User Fee Act (PDUFA), which gives the Food and Drug Administration (FDA) the resources to sustain a predictable …

Continue reading »

Jun 08

New FDA Guidances for May 2018

By Joanne McNelis, PhD, RAC (US), Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH, in April are posted. In addition, upcoming advisory committee meetings are listed below with links to more information.   Special Interest Guidances/Information Date Posted Development of a Shared System REMS Guidance for Industry – Draft …

Continue reading »

May 16

New Meeting Opportunities with FDA through the Model-Informed Drug Development (MIDD) Pilot Program

Our Regulatory Experts Can Help!

By Joshua Taylor, Ph.D., R.A.C. (US), Regulatory Scientist   The Prescription Drug User Fee Act (PDUFA) reauthorization for fiscal years (FYs) 2018 to 2022, known as PDUFA VI, includes language to facilitate the development and application of exposure-based, biological, and statistical models derived from preclinical and clinical data sources, referred to as model-informed drug development …

Continue reading »

May 07

New FDA Guidances for April 2018

By Joanne McNelis, PhD, RAC (US), Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH, in April are posted. In addition, upcoming advisory committee meetings are listed below with links to more information.   Special Interest Guidances/Information Date Posted Multiple Function Device Products: Policy and Considerations – Draft Guidance …

Continue reading »

Apr 13

New FDA Guidances for February and March 2018

By Joanne McNelis, PhD, RAC (US), Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH, in February and March are posted. In addition, upcoming advisory committee meetings are listed below with links to more information.   Special Interest Guidances/Information Date Posted Chronic Obstructive Pulmonary Disease: Use of the St. …

Continue reading »

Older posts «

» Newer posts