FTC Seeking Public Comment on Follow-On Biologics

The Federal Trade Commission (FTC) is seeking public comment on follow-on biologics.

In addition, the FTC will hold a public workshop on December 1oth.

The Follow-On Biologics Workshop: Impact of Recent Legislative and Regulatory Naming Proposals on Competition

The  Federal Trade Commission announces it will hold a workshop to explore  competition issues involving biologic medicines and follow-on biologics. As  described in the Federal Register Notice, the workshop will focus on a few key  issues, inter alia:

  • The potential impact of state regulations affecting competition.
  • How regulations, if necessary, might be structured to facilitate competition  while still protecting patient health and safety.
  •   How naming may affect competition.
  • The experience of other countries with follow-on biologic competition.

The  Federal Register Notice poses a series of questions about which the FTC seeks  public comment. The FTC will take these comments into account in its  examination of these topics.

Previous Biologics Workshops and Report:

Event Details

WHEN:

December 10, 2013 Time: 9am – 5pm

WHERE:

FTC Conference Center

601 New Jersey Avenue, NW

Washington, DC

Learn more at http://www.ftc.gov/opp/workshops/biologics/#nj

SGB and Yulex Partner to Double Guayule Rubber Yield Through an Accelerated Breeding Platform

SAN DIEGO, CA and PHOENIX, AZ–(Marketwired – Nov 12, 2013) –  SGB Inc., an agricultural biotechnology company, and Yulex  Corporation, a biomaterial company, announced today a collaboration to establish  a genomics and molecular breeding platform focused on accelerating the crop  improvement of Guayule as a sustainable source of biorubber that can replace  traditional tropical or petroleum-based rubber for medical, consumer and  industrial markets.Continue reading

Opportunity Alert:Medical Director at Celebration Stem Cell Centre

celebration stem cell

 

Celebration Stem Cell Centre, an AABB accredited and FDA registered public and private cord blood bank located in Gilbert, AZ is actively seeking a Medical Director.

Candidates must be a licensed physician that is qualified by training or experience in bone marrow and cord blood transplantation.  The Medical Director shall have responsibility and authority for all medical activities related to procurement, processing, and provision of the cellular therapy products and related services and to ensure that these activities are compliant with AABB, FDA and NMDP requirements.  The Medical Director will work closely with the current Laboratory Director and Quality Director in respect to the following responsibilities:

  • Review and approval of Standard Operating Procedures (SOPs)
  • Review of Nonconforming Products
  • Medical Review of donor records and test results prior to product release
  • Review of Proficiency testing results
  • Review of validation data of new processes/procedures
  • Review of Processing data when applicable
  • Participation in Quarterly Quality Meetings
  • Participate in Continuing Education Relevant to cord blood

All qualified individuals are encouraged to apply for this position.  Please send a copy of your C.V. and cover letter to info@csccaz.com.

SEC Releases Crowd Funding Rules for Non-Accredited Investors Under the JOBS Act.

On October 25, 2013, The Securities and Exchange Commission (SEC) released the Proposed Rules to govern the implementation of crowd funding by non-accredited investors under the JOBS Act.   Comments will be open for a 90 day  public comment period from the date that the proposed regs appear on the Federal Register. (As of this writing, the proposed regs have not yet been posted.) Continue reading