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Public Hearing on GDUFA Regulatory Science Initiatives

FDA will be holding a public hearing on June 5 to discuss regulatory science initiatives related to the Generic Drug User Fee Act (GDUFA). The hearing is designed to obtain input from industry on the identification of regulatory science priorities for FY 2016.

Office of Regulatory Science and Innovation Science Symposium

In late February, FDA announced its 2015 Office of Regulatory Science and Innovation Science Symposium, to be held on April 27. The symposium is designed to increase scientific collaborations with government institutions to improve training and advance regulatory science.

Compounding Advisory Committee Meeting

In late February, FDA’s Compounding Advisory Committee held a meeting on implementing the compounding provisions (Title 1) of the Drug Quality and Security Act (DQSA). The first part of the meeting discussed proposed revisions to the list of drug products that may not be compounded, while the second part focused on the criteria for developing […]

Advisory Meeting on Celltrion’s Infliximab Biosimilar Delayed

A meeting to evaluate Celltrion’s biosimilar infliximab, scheduled for March 17, has been delayed. The product is a biosimilar of J&J’s Remicade and is the first biosimilar mAb filed in the US. No new date has been set. The reason for the delay was given as “information requests pending with the sponsor.”

Asian Agencies Report on Progress in Addressing Emerging Regulatory Challenges at CASSS Biotech CMC Strategy Forum in Japan

Asian medicines agencies are joining those in the US and Europe in seeking to address the emerging regulatory challenges posed by: ● new classes of products such as cell-based regenerative medicines and engineered antibodies ● accelerated approval pathways ● biosimilars ● international convergence, and ● validation lifecycle management....

Mandatory EMA Electronic Applications

Starting July 1, EMA will only accept electronic applications for initial marketing authorisations, variations, and renewals for human and veterinary drugs. Next January, applications in Word format will no longer be filable and only eCTD versions of the electronic application will be accepted. These measures are designed to reduce administrative burden, while also improving data […]

EMA Weekly Start Dates for Type II Variations

Beginning in March, EMA announced it would introduce weekly start dates to facilitate the assessment of type II and worksharing variation applications. This change is expected to provide more flexibility and streamline the assessment process.

Biotechnology Office Reshaped under Office of Pharmaceutical Quality

Following its inclusion into the Office of Pharmaceutical Quality (OPQ), CDER’s Office of Biotechnology Products (OBP) will be reshaped. Previously the office had two divisions, one for mAbs and one for other proteins. Now, a central OBP group will evaluate INDs, NDAs, and BLAs and assign theme to an appropriate review team in one of […]

Draft Guidances on Compounding

In mid-February, FDA issued five draft guidances on policies for compounding and repackaging. One draft covers whether a company should register as an outsourcing facility, while another discusses regulations around repackaging by outsourcing facilities. A draft on biologics repackaging covers when the agency will not take action against facilities lacking a BLA. The other two […]

Allotrope Analytical Lab Data Standardization Effort Gaining Momentum with Better Analytical and Control Processes at Stake

The industry-based Allotrope Foundation is picking up momentum in its ambitious effort to create a framework for standardizing and sharing lab data, with more effective analytical and manufacturing control processes at stake....
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