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Submissions received: Regulation of autologous stem cell therapies The TGA sought comments from interested parties on Regulation of autologous stem cell therapies, regarding whether the regulation applied to some autologous cells is appropriate, in a consultation that closed on 3 March 2015. A total of 80 submissions were received. Of the submissions 14 from professional bodies, 12 from researchers, institutions or hospitals, 4 from industry groups, 4 from consumer groups, 20 from manufacturers, suppliers or health practitioners providing autologous stem cell therapies (businesses), 21 from patients and 5 from government bodies or other stakeholders.

Therapeutic Goods Administration (TGA) The TGA is planning to implement software to validate, review and process electronic submissions for the entry of registered medicines on to the Australian Register of Therapeutic Goods (ARTG) in 2015. Other regulated products are not currently included in the project to implement eCTD submissions. This software will be used for submissions in both electronic Common Technical Document (eCTD) and non eCTD (NeeS) formats. Embryo editing sparks epic debate Yorgos Nikas/SPL Human embryos are at the centre of a debate over the ethics of gene editing. In a world first, Chinese scientists have reported that they have used powerful gene-editing techniques to modify human embryos.

Consultation: Regulation of autologous stem cell therapies: Discussion paper for consultation Closing date: 3 March 2015 Invitation to comment The TGA is seeking comments from interested parties on Regulation of autologous stem cell therapies - Discussion paper for consultation. Consultation documents How to access a pdf or Word document Gene-editing summit supports some research in human embryos Feng Zhang, a synthetic biologist at the Massachusetts Institute of Technology who develops gene-editing technology, speaks at the summit. Gene-editing technology should not be used to modify human embryos that are intended for use in establishing a pregnancy, an international summit declared in a statement issued on 3 December. The International Summit on Human Gene Editing also called for cautious development of medical applications that cannot be passed on to offspring — such as correction of the mutations that cause sickle-cell disease or modification of immune cells to target cancer. But the summit statement, authored by a 12-member organizing committee, cautioned that many technical and ethical issues should be settled before anyone attempts ‘germline’ editing — the deletion of a gene prenatally in an effort to erase an inherited disease from an embryo and prevent it from being passed on to future generations.

Update 2: EU DCP: International collaboration for the evaluation of generic drugs The TGA is participating in an international collaboration programme led by the European Union (EU) under the auspices of the IGDRP through which, upon request from a generic pharmaceutical company, the assessment reports generated as part of EU Marketing Authorisation procedures will be shared in real time with collaborating regulatory agencies outside the EU such as the TGA. The IGDRP was launched in April 2012 with the aim of regulatory agencies to pursue collaboration and convergence to mitigate challenges of worldwide generic global development and approval programs. As part of the IGDRP, an information sharing pilot has been initiated in July 2014 using the European Union's Decentralised Procedure (DCP) as a model for the sharing of information during the scientific assessment phases of the DCP with IGDPR non-EU agencies, including the TGA. The first phase of the pilot project will involve the EU, Australia, Canada, Chinese Taipei and Switzerland.

Where in the world could the first CRISPR baby be born? They are meeting in China; they are meeting in the United Kingdom; and they met in the United States last week. Around the world, scientists are gathering to discuss the promise and perils of editing the genome of a human embryo. Should it be allowed — and if so, under what circumstances? The meetings have been prompted by an explosion of interest in the powerful technology known as CRISPR/Cas9, which has brought unprecedented ease and precision to genetic engineering.

Awakening the Third Eye – Be Careful What You Wish For Gregg Prescott, In5D GuestWaking Times Have you ever heard the expression, ‘Be careful what you wish for’? For some people, the opening of the 3rd eye can show them things that they really didn’t want to see. For others, it’s a journey of enlightenment. If you are sure that this is something you want to do, then please read on.

Statement of Task, International Summit on Human Gene Editing, Dec. 1-3, 2015 International Summit on Human Gene Editing Statement of Task and Planning Committee The National Academy of Sciences, National Academy of Medicine, Chinese Academy of Sciences, and the Royal Society of the UK will organize an International Summit in Washington, D.C., in December 2015 on recent scientific developments in human gene editing and the range of ethical and governance issues associated with these advances. The meeting will consider issues such as the current state of the science and available technologies; the rationale(s) for and potential benefits and risks inherent in conducting such research and in potential applications; existing (as well as potentially needed) regulatory principles, standards, or guidance for such research and potential applications; ethical concerns; legal considerations; and ways to engage critical stakeholders. An ad hoc committee will organize the meeting as well as commission papers to inform the discussions.

Iboga, the Matrix, and Pineal Gland Decalcification Dylan Charles, StaffWaking Times The pineal gland has been at the core of spiritual traditions dating back thousands of years, spanning all inhabited continents. Prominently carved onto Buddhist statues, ceremoniously painted onto tribal faces, and deceptively displayed in the Vatican square, the pineal gland, known as the Third Eye, or Seat of the Soul, is still shrouded in mystery.

Text - S.2388 - 114th Congress (2015-2016): Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2015 To amend the Federal Food, Drug, and Cosmetic Act to provide for reciprocal marketing approval of certain drugs, biological products, and devices that are authorized to be lawfully marketed abroad, and for other purposes. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, SECTION 1. The Spiritual Eye: How to Decalcify & Activate Your Pineal Gland Christina Sarich, ContributorWaking Times This article will presume you have a basic knowledge of the pineal gland, an important endocrine gland that is said to be the seat of enlightenment. If you need to back up a little and inform yourself more about what the pineal gland is, you can start here before reading further. Activating your pineal gland, or spiritual ‘eye’ and detoxing it are two different things. In essence, the detoxification allows you to remove the crystallized deposits, which keep the gland as a caged bird, or a princess jailed in her own ivory tower.

Could The RESULT Act End The FDAs Monopoly On Drug Approval By Ed Miseta, Chief Editor, Clinical LeaderFollow Me On Twitter @EdClinical If a pharmaceutical company would like to get a drug approval in the U.S., there is but one agency that can do it: the FDA. This set-up is what economists would refer to as a state-sponsored monopoly, where one entity in granted the sole authority to provide a good or service. While multiple producers can promote lower prices, greater efficiencies, and choice, a monopoly has the advantage of being easier to regulate and control. Unfortunately, with only one provider, they can also be delays and shortages.

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