Authored by Hogan Lovells Regulatory Lawyers, Focus on Regulation covers international government regulations across a number of industries.
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Focus on Regulation | Government Regulatory Lawyers | Hogan Lovells | hlregulation.com Reviews
https://hlregulation.com
Authored by Hogan Lovells Regulatory Lawyers, Focus on Regulation covers international government regulations across a number of industries.
hlregulation.com
EMA Medicinal Products | Focus on Regulation
https://www.hlregulation.com/tag/ema-medicinal-products
Published by Hogan Lovells. We offer timely, effective counsel on a wide variety of matters. Continue Reading ». Tag Archives: EMA Medicinal Products. August 4th, 2015. PUBLIC CONSULTATION PROCESS LAUNCHED ON DRAFT REVISED GUIDELINE CONCERNING THE CONDITIONAL MARKETING AUTHORISATION PROCEDURE FOR MEDICINAL PRODUCTS. August 4th, 2015. PUBLIC CONSULTATION PROCESS LAUNCHED ON DRAFT REVISED GUIDELINE CONCERNING ACCELERATED ASSESSMENT OF MEDICINAL PRODUCTS. July 8th, 2015. On 25 June 2015, the Committee for M...
EMA | Focus on Regulation
https://www.hlregulation.com/tag/ema
Published by Hogan Lovells. We offer timely, effective counsel on a wide variety of matters. Continue Reading ». August 25th, 2016. EMA Publishes New GMP Guidance on Data Integrity. June 14th, 2016. Four New Public Consultations on Clinical Trials. On 1 June 2016 the European Commission (“EC”) launched four new public consultations relating to clinical trials. June 2nd, 2016. Draft reflection paper on non-spontaneous adverse event reports. April 21st, 2016. April 21st, 2016. European Medicines AgencyR...
International Government Regulations Topics | Focus on Regulation
https://www.hlregulation.com/topics
Published by Hogan Lovells. We offer timely, effective counsel on a wide variety of matters. Continue Reading ». Antitrust, Competition and Economic Regulation. Today’s global businesses face a challenging framework of antitrust and competition laws in jurisdictions around the world. Hogan Lovells’ Antitrust, Competition and Economic Regulation. Team is ideally placed to help clients deal with these effectively. And its partners regularly receive first-tier rankings from. Which notes that we. We represen...
AWS-3 Auction Ownership Information | Focus on Regulation
https://www.hlregulation.com/2014/10/08/aws-3-auction-ownership-information
Published by Hogan Lovells. We offer timely, effective counsel on a wide variety of matters. Continue Reading ». Technology, Media and Telecoms. AWS-3 Auction Ownership Information. October 8th, 2014. AWS-3 Auction Ownership Information. Last week, the Commission released the list of 80 applicants. 2014 AWS Spectrum Bidco Corporation. John A. Dooley. TerreStar Corporation (Insulated LP, 99% Equity, 0% Vote; Highland Crusader, Sola Ltd, and West Face hold interests in TerreStar). Paul W. Chisholm. David A...
The EMA Publishes New Biosimilars Guideline on Non-Clinical and Clinical Issues | Focus on Regulation
https://www.hlregulation.com/2015/01/15/the-ema-publishes-new-biosimilars-guideline-on-non-clinical-and-clinical-issues
Published by Hogan Lovells. We offer timely, effective counsel on a wide variety of matters. Continue Reading ». The EMA Publishes New Biosimilars Guideline on Non-Clinical and Clinical Issues. January 15th, 2015. The EMA Publishes New Biosimilars Guideline on Non-Clinical and Clinical Issues. S (hereafter EMA Guideline ). The revised EMA Guideline is expected to come into force in July 2015 and will replace the current guideline. Which came into effect in June 2006. Design of non-clinical studies;.
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FDA Anticipates New Draft Biosimilar Guidances | Biosimilars Law Blog
http://www.biosimilarslawblog.com/2014/02/06/fda-anticipates-new-draft-biosimilar-guidances
With more than 100 lawyers serving the pharmaceutical and biotechnology sectors, we offer timely, effective counsel on a wide variety of matters. Continue Reading ». FDA Anticipates New Draft Biosimilar Guidances. February 6th, 2014. By Marie A. Vodicka. Posted in News and Events. FDA Anticipates New Draft Biosimilar Guidances. Including biosimilars in the release of expected 2014 CDER draft guidance documents. Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product.
biosimilar | Biosimilars Law Blog
http://www.biosimilarslawblog.com/tag/biosimilar
With more than 100 lawyers serving the pharmaceutical and biotechnology sectors, we offer timely, effective counsel on a wide variety of matters. Continue Reading ». June 23rd, 2016. Posted in Global Comparisons. AIFA publishes “Second Concept Paper” on biosimilars. April 13th, 2015. By Hein van den Bos. Posted in Global Comparisons. Netherlands MEB revises position on biosimilars and interchangeability. April 16th, 2012. By Marie A. Vodicka. Posted in News and Events. While a Supreme Court ruling on the...
biosimilarity | Biosimilars Law Blog
http://www.biosimilarslawblog.com/tag/biosimilarity
With more than 100 lawyers serving the pharmaceutical and biotechnology sectors, we offer timely, effective counsel on a wide variety of matters. Continue Reading ». June 23rd, 2016. Posted in Global Comparisons. AIFA publishes “Second Concept Paper” on biosimilars. June 23rd, 2015. By Marie A. Vodicka. Posted in News and Events. FDA Updates U.S. Biosimilar Guidances. April 17th, 2015. By Marie A. Vodicka. Posted in News and Events. The First Biosimilar in the U.S. Five Questions Left Open by FDA. Last m...
FDA Biosimilars Guidances | Biosimilars Law Blog
http://www.biosimilarslawblog.com/tag/fda-biosimilars-guidances
With more than 100 lawyers serving the pharmaceutical and biotechnology sectors, we offer timely, effective counsel on a wide variety of matters. Continue Reading ». Tag Archives: FDA Biosimilars Guidances. July 15th, 2016. And Marie A. Vodicka. Posted in Biosimilar labeling. FDA Denies Three Petitions on Biosimilar Labeling: Refers Petitioners to Guidance Process. August 31st, 2015. By Marie A. Vodicka. Posted in Biosimilar Definitions. June 23rd, 2015. By Marie A. Vodicka. Posted in News and Events.
BPCIA | Biosimilars Law Blog
http://www.biosimilarslawblog.com/tag/bpcia
With more than 100 lawyers serving the pharmaceutical and biotechnology sectors, we offer timely, effective counsel on a wide variety of matters. Continue Reading ». March 16th, 2016. Marie A. Vodicka. Jason F. Conaty. Posted in Biosimilars Patent Exchange. FDA Guidance on Transition Biological Products: Implications for Exclusivity and Patent Listings. October 7th, 2014. Posted in Biosimilar Definitions. Hogan Lovells on Facebook. Hogan Lovells on Linkedin. Hogan Lovells on Twitter. Subscribe to this bl...
First Licensure | Biosimilars Law Blog
http://www.biosimilarslawblog.com/tag/first-licensure
With more than 100 lawyers serving the pharmaceutical and biotechnology sectors, we offer timely, effective counsel on a wide variety of matters. Continue Reading ». Tag Archives: First Licensure. October 7th, 2014. Posted in Biosimilar Definitions. FDA Issues Draft Guidances on Reference Product Exclusivity for Biological Products and Clinical Pharmacology for Biosimilars. Hogan Lovells on Facebook. Hogan Lovells on Linkedin. Hogan Lovells on Twitter. Subscribe to this blog via RSS. HL Chronicle of Data...
Biosimilar Definitions | Biosimilars Law Blog
http://www.biosimilarslawblog.com/biosimilar-definitions
With more than 100 lawyers serving the pharmaceutical and biotechnology sectors, we offer timely, effective counsel on a wide variety of matters. Continue Reading ». Category Archives: Biosimilar Definitions. Subscribe to Biosimilar Definitions RSS Feed. August 31st, 2015. By Marie A. Vodicka. Posted in Biosimilar Definitions. FDA Announces Policy for Unique Nonproprietary Names for Biologics and Biosimilars. October 7th, 2014. Posted in Biosimilar Definitions. May 22nd, 2013. Posted in Biosimilar Defini...
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HL Real Estate Group. Charlotte Real Estate
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Focus on Regulation | Government Regulatory Lawyers | Hogan Lovells
Published by Hogan Lovells. We offer timely, effective counsel on a wide variety of matters. Continue Reading ». March 28th, 2018. By Julia Fraser and Jane Summerfield. UK Parliamentary Committee Publishes Life Sciences Brexit Negotiation Recommendations. The report also sets out a number of more detailed recommendations as to the position that the UK Government should adopt in the Brexit negotiations, including seeking:. Continued access to EU data sharing networks and pharmacovigilance systems, includi...
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