Tag Archive: FDA

Feb 20

New FDA Guidances for January 2018

By Sheila Plant, PhD, MHS, RAC (US), Assistant Director, Regulatory Strategy, US, Cato Research   FDA draft and final guidances released from CDER, CBER, and CDRH in January 2018 are posted.  CDRH has also released an “A-list” and a “B-list” of proposed guidances for fiscal year 2018 and is seeking feedback on the relative priority …

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Jan 22

Communicating with the FDA: Important Changes to Formal Meetings with FDA for PDUFA Products

By: Robert McNeill, Ph.D., Scientist at Cato Research In December 2017, to address changes under PDUFA VI, the FDA published a draft guidance for industry titled Formal Meetings between the FDA and Sponsors or Applicants of PDUFA Products (Version date: 18 December 2017) (2017 PDUFA Meetings draft guidance). At the same time, two guidance documents were …

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Jan 05

New FDA Guidances for December 2017

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 December 2017 are posted. In addition, upcoming advisory committee meetings are listed below with links to more information. Special Interest Guidances/Information Date Posted Labeling for Combined Hormonal Contraceptives – Draft Guidance …

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Dec 20

New FDA Guidances for October and November 2017

By Michelle Villasmil, Ph.D., RAC (US), Regulatory Scientist at Cato Research FDA draft and final guidances released from CDER, CBER, and CDRH and Manual of Policies and Procedures (MAPPs) of interest released from CDER in October and November 2017 are posted. Currently, there are no upcoming advisory committee meetings. Special Interest Guidances/Information Date Posted Select …

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Dec 07

Toward Compliance 2.0 : When your Pill is Connected to your Smartphone

By: David Hamel, Fellow Scientist Cato Research Canada The FDA approval of Abilify MyCite (aripiprazole tablets with sensor; by Otsuka) on 13 November 2017 for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults could mark a …

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Oct 11

New FDA Guidances for September 2017

By Michelle Villasmil, Ph.D., RAC (US), Regulatory Scientist at Cato Research FDA draft and final guidances released from CDER, CBER, and CDRH and Manual of Policies and Procedures (MAPPs) of interest released from CDER in September 2017 are posted. In addition, upcoming advisory committee meetings are listed below with links to more information.   Special …

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Sep 08

New FDA Guidances for August 2017

By Michelle Villasmil, Ph.D., RAC (US), Regulatory Scientist at Cato Research FDA draft and final guidances released from CDER, CBER, and CDRH and Manual of Policies and Procedures (MAPPs) of interest released from CDER in August 2017 are posted. In addition, upcoming advisory committee meetings are listed below with links to more information. Special Interest …

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Aug 14

New FDA Guidances for July 2017

By Michelle Villasmil, Ph.D., RAC (US), Regulatory Scientist at Cato Research FDA draft and final guidances released from CDER, CBER, and CDRH and Manual of Policies and Procedures (MAPPs) of interest released from CDER in July 2017 are posted. In addition, upcoming advisory committee meetings are listed below with links to more information. Special Interest …

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Jul 14

FDA Updates ICH E14 Q&A Modelling in QTc Prolongation Studies

Greg Hileman, Ph.D., Sr. Director and Principle Regulatory Scientist of Cato Research The International Conference on Harmonization (ICH) last updated its guidance “THE CLINICAL EVALUATION OF QT/QTC INTERVAL PROLONGATION AND PROARRHYTHMIC POTENTIAL FOR NON-ANTIARRHYTHMIC DRUGS (ICH E14 (R3)) in 2005. This month, FDA published the most recent ICH updated list of questions and answers (ICH …

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Jul 10

New FDA Guidances for June 2017

By Michelle Villasmil, Ph.D., RAC (US), Regulatory Scientist at Cato Research FDA draft and final guidances released from CDER, CBER, and CDRH and Manual of Policies and Procedures (MAPPs) of interest released from CDER in June 2017 are posted. In addition, upcoming advisory committee meetings are listed below with links to more information.   Special …

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