Category Archive: Industry News

Jul 23 2019

Complicated Drug Product? FDA Releases New Draft Guidance on Instructions for Use to Help Sponsors Communicate Proper Use to the Patient

By Dieanira Erudaitius, Ph.D, Scientist at Cato Research This month, July 2019, the United States Food and Drug Administration (FDA) released a new draft guidance to meet Prescription Drug User Fee Act (PDUFA) VI performance goals for patient‑oriented labeling. This draft guidance provides recommendations on the content and format development for Instructions for Use (IFU) …

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May 10 2019

New FDA Guidance’s for April 2019

Special Interest Guidances/Information Date Posted Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices: Guidance for Industry and Food and Drug Administration Staff – Final Guidance 26 Apr 2019 Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions: Guidance for Industry and Food and Drug Administration Staff – Final …

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Mar 02 2015

New FDA Guidances for February 2015

By Sheila R. Plant, Ph.D., R.A.C., Regulatory Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH in February 2015, are posted.  Two updates to the CDER Manual of Policies and Procedures (MAPP) are included.  In addition, upcoming advisory committee meetings to be held in the next couple months are …

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Mar 31 2014

New FDA Guidances for March 2014

By Sheila R. Plant, Ph.D., R.A.C., Regulatory Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH in March, are posted.  In addition, upcoming Advisory committee meetings, other public meetings hosted by FDA, as well as CDRH’s 2014 Strategic Priorities are listed below with links to more information on each. …

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Mar 03 2014

New FDA Guidances for February 2014

By Sheila R. Plant, Ph.D., R.A.C., Regulatory Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH in February, are posted.  In addition, the upcoming Advisory committee meetings and other public meetings hosted by FDA are listed below with links to more information. Special Interest Guidances/Information Date Posted Distributing Scientific and …

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Jan 30 2014

FDA’s Comprehensive Status Report on Personalized Medicine

By Sheila R. Plant, Ph.D., R.A.C., Regulatory Scientist at Cato Research FDA published a report, prepared by the Office of the Commissioner in the Office of Medical Products and Tobacco, in October 2013 entitled “Paving the Way for Personalized Medicine: FDA’s Role in a New Era of Medical Product Development” with an enthusiastic forward by …

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Jan 06 2014

New FDA Guidances for December 2013

Special Interest Guidances/Information Date Posted Guideline for Industry and Food and Drug Administration Staff – Class II Special Controls Guideline: Temporary Mandibular Condyle Reconstruction Plate 30 Dec 2013 Naming of Drug Products Containing Salt Drug Substances (PDF – 161KB) 24 Dec 2013 Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules (PDF – 75KB) 09 …

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Oct 10 2013

New FDA Guidances for September 2013

September was a big month for CDRH Guidances.  Both the final Mobile Medical Applications Guidance and the much awaited Guidance on the Unique Device Identification Database were released.  More information about the Unique Device Identifier program can be found here. Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration Generic Drug User Fee Amendments …

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Sep 19 2013

New FDA Guidances for August 2013

New guidances out last month include several device related guidances including a beloved (at least by me) Q&A guidance on GLPs in premarket device submissions; a listing of FY 2014 medical device small business user fees; and new information on risk-based monitoring, which is being pushed both by FDA and industry. Select Updates for Non-Clinical …

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Aug 13 2013

New FDA Guidances for July 2013

Another month with lots of new and updated guidances released.  Two guidances highlight clinical design considerations for specific therapies: Antibacterial Therapies for Patients With Unmet Medical Need for the Treatment of Serious Bacterial Diseases and Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products. Medical Device Reporting for Manufacturers Antibacterial Therapies …

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