Category Archive: Industry News

Mar 02

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 …

Continue reading »

Mar 31

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. …

Continue reading »

Mar 03

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 …

Continue reading »

Jan 30

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 …

Continue reading »

Jan 06

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 …

Continue reading »

Oct 10

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 …

Continue reading »

Sep 19

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 …

Continue reading »

Aug 13

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 …

Continue reading »

May 21

New FDA Guidances for April 2013

There were many new Guidances out in April.  Notably, changes in postmarketing periodic safety reporting are discussed in this guidance.  See CATO’s take on some of the changes in postmarket reporting here. SUPAC: Manufacturing Equipment Addendum  Glass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4 …

Continue reading »

Apr 11

New FDA Guidances for March 2013

FDA released several interesting new guidances last month, including several regarding communications with the FDA. Types of Communication During the Review of Medical Device Submissions is in accordance with the MDUFA III goals and includes descriptions of acceptance review communications, substantive interactions, interactive review, and missed MDUFA decision communications. Formal Meetings Between the FDA and Biosimilar …

Continue reading »

Older posts «