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FDA Advisory Committee Members Sought

FDA announced in the Federal Register in mid-April that it is seeking input from the pharmaceutical and biopharmaceutical industry for input on which industry experts should serve on 18 of its Center for Drug Evaluation and Research (CDER) advisory committees. The announcement noted that anyone interested in participating on the committees may nominate themselves. Committee […]

Final Guidances on Biosimilars

In late April, FDA released three final guidance documents covering biosimilars. The drafts of the three were released in early 2012 as required by the 2010 Biologics Price Competition and Innovation Act (BPCIA). The first is a Q&A document covering: ● biosimilarity and interchangeability ● provisions related to requirement to submit a BLA for a […]

21st Century Cures Act

In late April, the U.S. House Energy and Commerce Committee released an updated “discussion draft” of the “21st Century Cures Act” – a piece of legislation that has been under development for over a year. It is intended to speed up the approval process for medicines that treat conditions currently lacking cures, and contains numerous […]

Fixed-Dose Combination Product Regulations

FDA announced in late May its intent to release regulations this year on “fixed-dose combination and co-packaged drug and/or biological products.” The regulations will also apply to fixed dose drug/biological combination products and certain natural source and synthetic drugs. They will describe the circumstances under which the agency might waive the combination requirements for a […]

Electronic Drug and Biologic Submissions

In early May, FDA published a final guidance on electronic common technical document (eCTD) submissions. Per provisions in the FDA Safety and Innovation Act (FDASIA) section 1136, the guidance publication begins a two-year countdown to the requirement for all new drug and biological product submissions to be sent to the agency electronically. Commercial INDs will […]

FDA “Outdated” Guidance Documents

FDA withdrew 47 guidance documents in early May after regulators declared them “unfinished and outdated.” The notice of the withdrawal was published in an early May Federal Register. The guidances that were withdrawn were incomplete or had been put on hold, during which time new scientific developments or shifts in regulatory policy rendered them irrelevant. A […]

New Biosimilar Manufacturers Coalition

In early May, a coalition of 11 leading companies involved in the development and manufacturing of biopharmaceuticals and biosimilar medicines announced the formation of the “Biosimilars Forum” – the first nonprofit organization dedicated to expanding patient access to biosimilars in the U.S. The founding members of the Biosimilars Forum include Actavis, Amgen, Boehringer Ingelheim, Coherus […]

Sanofi is Coordinating the Lifecycle Management of its Automation Systems to Head Off Manufacturing Breakdowns

Sanofi is focusing more attention on coordinating the lifecycle management of its automation systems to head off the major threats to the continuity of manufacturing operations that ensue from not having a well thought-out planning process in place....

Pharma May be Missing 80% of the Power of Deming’s Methods, Deming Institute Expert Maintains at PDA/FDA Q10 Workshop

Deming Institute Advisory Board Chairman Kelly Allen maintained at a PDA/FDA Pharmaceutical Quality System (ICH Q10) Workshop on Quality Risk Management that the pharmaceutical industry has, in general, been missing 80% of the power of Deming’s management methods, which involve understanding: ● the organization as a system ● variation ● the theory of knowledge, and ● human psychology....

High Foreign Inspection Failure Rate Indicates Need for Better Pharma Risk Modeling and Supplier Oversight Abroad, FDA Compliance Official Stresses

The current high FDA foreign inspection failure rate points to the need for the pharmaceutical industry to develop better risk models and intensify supplier oversight abroad, a senior official at the Center for Drug Evaluation and Research (CDER) Office of Compliance (OC) is stressing....
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