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Cato Research Blog » Expertise and Research in Drug Development - Clinical and Regulatory through Approval | ask-cato.com Reviews
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guidance Archives - Ask Cato ResearchAsk Cato Research
http://www.ask-cato.com/tag/guidance
New FDA Guidances for July 2016. By Yuka Fukushima, Regulatory Associate and Compliance Specialist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH from July 2016, are posted. In addition, upcoming advisory committee meetings to be held are also listed below … Continue reading →. Click to share on Google (Opens in new window). Click to share on Twitter (Opens in new window). Share on Facebook (Opens in new window). Click to share on Pinterest (Opens in new window). By Br...
IND Archives - Ask Cato ResearchAsk Cato Research
http://www.ask-cato.com/tag/ind
Jump on the Development Safety Update Report (DSUR) Bandwagon! By Amelie Rodrigue-Way, Ph.D., RAC (CAN), Clinical Scientist, Cato Research Canada. If you have an open Investigational New Drug application (IND) then you are all too familiar with the periodic reporting requirements. Many US-based sponsors have opted for the Annual … Continue reading →. Click to share on Google (Opens in new window). Click to share on Twitter (Opens in new window). Share on Facebook (Opens in new window). Click to share on ...
FDA Archives - Ask Cato ResearchAsk Cato Research
http://www.ask-cato.com/category/fda
New FDA Guidances for July 2016. By Yuka Fukushima, Regulatory Associate and Compliance Specialist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH from July 2016, are posted. In addition, upcoming advisory committee meetings to be held are also listed below … Continue reading →. Click to share on Google (Opens in new window). Click to share on Twitter (Opens in new window). Share on Facebook (Opens in new window). Click to share on Pinterest (Opens in new window). By Ha...
safety Archives - Ask Cato ResearchAsk Cato Research
http://www.ask-cato.com/tag/safety
Jump on the Development Safety Update Report (DSUR) Bandwagon! By Amelie Rodrigue-Way, Ph.D., RAC (CAN), Clinical Scientist, Cato Research Canada. If you have an open Investigational New Drug application (IND) then you are all too familiar with the periodic reporting requirements. Many US-based sponsors have opted for the Annual … Continue reading →. Click to share on Google (Opens in new window). Click to share on Twitter (Opens in new window). Share on Facebook (Opens in new window). Click to share on ...
Regulatory Strategy Archives - Ask Cato ResearchAsk Cato Research
http://www.ask-cato.com/category/regulatory-strategy
Category Archives: Regulatory Strategy. New FDA Guidances for July 2016. By Yuka Fukushima, Regulatory Associate and Compliance Specialist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH from July 2016, are posted. In addition, upcoming advisory committee meetings to be held are also listed below … Continue reading →. Click to share on Google (Opens in new window). Click to share on Twitter (Opens in new window). Share on Facebook (Opens in new window). Cato Research is...
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Cato Strategic Locations | Cato Research Communications Registry | Cato Research - Contract Research Organization | Research Triangle Park, Durham, North Carolina
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Chemistry, Manufacturing,. Data Management and Biostatistics. Preclinical / Nonclinical Services. Quality Clinical Trial Oversight. Cato Research has in-house capabilities to assist sponsors with all aspects of the drug development process. Obstetrics / Gynecology / Women’s Health. Regenerative Medicine / Cell Therapies / Stem Cells. Respiratory Disorder / Pulmonology. As an expanding contract research organization, Cato Research is constantly on the move, growing and keeping up-to-date with the latest a...
Archive of Past 3 Years of Cato Research News and Events | Press Releases | Cato Research - Contract Research Organization | Research Triangle Park, Durham, North Carolina
http://www.cato.com/cato-news-and-events_archive.shtml
Chemistry, Manufacturing,. Data Management and Biostatistics. Preclinical / Nonclinical Services. Quality Clinical Trial Oversight. Cato Research has in-house capabilities to assist sponsors with all aspects of the drug development process. Obstetrics / Gynecology / Women’s Health. Regenerative Medicine / Cell Therapies / Stem Cells. Respiratory Disorder / Pulmonology. As an expanding contract research organization, Cato Research is constantly on the move, growing and keeping up-to-date with the latest a...
Services | Clinical Trials, Regulatory Affairs, Preclinical, Project Management | Drug Development
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Chemistry, Manufacturing,. Data Management and Biostatistics. Preclinical / Nonclinical Services. Quality Clinical Trial Oversight. Cato Research has in-house capabilities to assist sponsors with all aspects of the drug development process. Obstetrics / Gynecology / Women’s Health. Regenerative Medicine / Cell Therapies / Stem Cells. Respiratory Disorder / Pulmonology. As an expanding contract research organization, Cato Research is constantly on the move, growing and keeping up-to-date with the latest a...
Team | BioPharm Physicians
http://www.biopharmphysicians.com/team
Comments Off on Steven Rauscher. Steve Rauscher has worked with physicians in the biopharmaceutical industry as colleagues, customers and partners throughout his career. His experience provides a unique perspective in helping connect physicians to opportunities in the industry and helping companies find the physicians they need. Earlier in his career, Steve held a number of leadership positions at Abbott Laboratories, including Vice President of Corporate Licensing, Vice President of Business Development...
SERVICES | BioPharm Physicians
http://www.biopharmphysicians.com/services
Comments Off on Consulting. We help you find physician consultants on short-notice for interim assignments and projects. These consultants can provide supplemental support to internal resources during times of peak effort. They can also step in and fill a gap created by sudden or unplanned turnover. Protocol development and medical monitoring. Due diligence and feasibility reviews. Clinical program design and execution. Regulatory planning and preparation. Drug safety and pharmacovigilance. Organizationa...
Blog | BioPharm Physicians
http://www.biopharmphysicians.com/category/blog
Drug Pricing & Reimbursement. PUBLISHED BY: Editor: BioPharm Physicians. Comments Off on Drug Pricing & Reimbursement. Julia Aledort Gaebler, Ph.D. Vice President, Health Advances. Dr Gaebler began by emphasizing three key messages for the audience:. 1 Global Health Technology Assessment (HTA) is proliferating and payers are gaining influence. 2 Payer evidence requirements have created a new ‘4th hurdle’ for manufacturers. Comparative effectiveness in a real world setting is increasingly required. Dr...
Blog | BioPharm Physicians
http://www.biopharmphysicians.com/blog
Drug Pricing & Reimbursement. PUBLISHED BY: Editor: BioPharm Physicians. Comments Off on Drug Pricing & Reimbursement. Julia Aledort Gaebler, Ph.D. Vice President, Health Advances. Dr Gaebler began by emphasizing three key messages for the audience:. 1 Global Health Technology Assessment (HTA) is proliferating and payers are gaining influence. 2 Payer evidence requirements have created a new ‘4th hurdle’ for manufacturers. Comparative effectiveness in a real world setting is increasingly required. Dr...
Cato Research News and Events | Biotechnology, Pharmaceuticals, Life Sciences | Research Triangle Park, Durham, North Carolina
http://www.cato.com/cato-news-and-events.shtml
Chemistry, Manufacturing,. Data Management and Biostatistics. Preclinical / Nonclinical Services. Quality Clinical Trial Oversight. Cato Research has in-house capabilities to assist sponsors with all aspects of the drug development process. Obstetrics / Gynecology / Women’s Health. Regenerative Medicine / Cell Therapies / Stem Cells. Respiratory Disorder / Pulmonology. As an expanding contract research organization, Cato Research is constantly on the move, growing and keeping up-to-date with the latest a...
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Cato Research Blog » Expertise and Research in Drug Development - Clinical and Regulatory through Approval
Deadline to Begin Submitting Commercial INDs in eCTD Format is May 5, 2018. By Joshua Taylor, Ph.D., R.A.C. (US), Regulatory Scientist Beginning on May 5, 2018, all commercial Investigational New Drug Applications (INDs) and master files must be submitted in the electronic common technical document (eCTD) format. Section 745A(a) of the Food, Drug, and Cosmetic Act (FD&C Act) authorizes the United States Food and Drug Administration (FDA) to …. New FDA Guidances for January 2018. By Sandra Salem, Ph.D...
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