Fourth Question of the Day October 30, 2013 Once the Federal Drug Quality and Security Act becomes law how will this effect insurance polices and cost? Will there be a new category for outsourcing facilities?

BREAKING NEWS URGENT MUST READ--SENATE IS WORKING ON DEAL TO CONSIDER Federal Compounding Legislation TODAY, October 30, 2013!!! stay tuned for more info as it becomes available!!!

We are also working on an agreement to consider H.R.3204, a bill to amend the Federal Food, Drug, and Cosmetic Act with respect to human drug compounding and drug supply chain security, as early as today

quoted from here

10/29/13 - PDA/FDA Joint Regulatory Conference: Great Place to Learn From Regulators

10/29/13 - PDA/FDA Joint Regulatory Conference: Great Place to Learn From Regulators

BETHESDA, Md., Oct. 29, 2013 /PRNewswire-USNewswire/ Many of the nearly 1,000 people who attended the 23rd Annual PDA/FDA Joint Regulatory Conference said the event provided them the opportunity to hear directly from regulators on the issues that affect them most, and from industry experts on how they are responding to these same issues. (Logo:http://photos.prnewswire.com/prnh/20130226/DC66667LOGO) Co-sponsored and co-planned by the PDA and the FDA, and held in Washington, D.C., the annual conference has become the place where those working in the pharmaceutical industry can join in discussions with representatives of the Food and Drug Administration to gain their perspectives. There were more than 45 FDA speakers, including Janet Woodcock, M.D., Director, CDER, FDA. Attendees come from across the globe. Many say the conference gives them more than in depth knowledge to take back to their firms. "In addition, for me as a lawyer, the many opportunities to hear directly from the FDA officials on what their current line of thinking is and what their visions on their expected policy changes are," said Daike Van de Putte, from GSK. "It was very insightful for me to learn the reasons behind such changes." Other attendees, who supply the pharmaceutical industry, said the conference helped them better understand their customers. "I came away with a deeper understanding of our customers' needs and challenges, along with critical information that enables us to become a better partner," said Ross. W. Acucena of EMD Millipore. "The 2013 PDA/FDA Joint Regulatory Conference was, as always, a priceless venue to connect with colleagues and FDA representatives," said Veronica Cruz, Ph.D., of Johnson & Johnson. The 2014 PDA/FDA Joint Regulatory Conference is scheduled for September 8-10. There is a workshop, entitled2014 PDA Drug Shortage Workshop on September 10-11. Courses from the renowned PDA Training and Research Institute will follow. About PDAThe Parenteral Drug Association (PDA) is the leading global provider of science, technology and regulatory information and education for the pharmaceutical and biopharmaceutical community. Founded in 1946 as a nonprofit organization, PDA is committed to developing scientifically sound, practical technical information and resources to advance science and regulation through the expertise of its more than 9,500 members worldwide. PDA's Annual Meeting will be held April 7-9, 2014 in San Antonio, Texas. For information, visit www.pda.org and follow PDA on LinkedIn. Press ContactAmelia Townsend Director of Marketing Services, Parenteral Drug Association (PDA), townsend@pda.org, 301-656-5900, ext. 153 SOURCE Parenteral Drug Association quoted from here

IMPORTANT! Passage Of Compounding Safety Bill Positions TherapeuticsMD In Hormone Therapy Market Oct 30 2013, 13:58 | about: TXMD

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. (More...)

We continue to remain positive on TherapeuticsMD Inc. (NYSEMKT:TXMD) shares, a specialty pharmaceuticals company developing advanced-stage pharmaceutical hormone replacement therapy (HRT) products. Shares of TXMD have been on the rise after the House of Representatives passed a compounding safety bill - The Drug Quality and Security Act. While the passage of the bill has surprised many, we had predicted in a previous article that the bill would likely be passed. Although the bill still has to pass through the Senate, its passage in the House is crucial having been seen as a major hurdle. Earlier in the week, the company also announced achievement of significant proof-of-concept in phase 1, first-in-class soft gel vaginal formulation TX12-004HR. In addition, the company also hired a clinical expert. Before discussing what kind of impact these developments could have on TherapeuticsMD, let us just recap what the House bill is in essence about.

Making HRT safer

As we discussed in the previous article, drugs that address a single hormonal issue or monotherapies do not work well in hormone therapy. This is due to the fact that when a drug suppresses one problem hormone, the levels of another problem hormone increase. This issue created a need for developing combination therapies for HRT. Currently, the only drugs for HRT that have been approved by the FDA are monotherapeutic bio-identicals. As a result, doctors have been forced to send women needing HRT to compounding pharmacies that create over-the-counter hormone therapies by compounding non-FDA approved synthetic drugs. These therapies unfortunately have severe side-effects such as cancer.