For more than 20 years, experts at Becker Consulting have helped client companies meet and exceed FDA requirements for developing, testing and marketing innovative healthcare products. We offer Becker™ quality services in the following practice areas:
- REGULATORY | Approval Strategy, FDA Interactions, Advisory Panels, 510(k), PMA, NDA and Other Submissions
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Becker & Associates at FDLI's "The Intersection Worlds of Drug, Device, Biologics, and Health Law"Please join BECKER CONSULTING at the Food and Drug Law Institute’s conference on “The Intersecting Worlds of Drug, Device, Biologics, and Health Law” next week at the St. Regis hotel in Washington, DC. The conference, co-sponsored by the American Health Lawyers Association, will take place on Monday and Tuesday, May 21-22, and will address three significant areas of intersection in FDA and Health Law: reimbursement, fraud and abuse, and research/clinical trial issues. More information and registration are available here:http://www.fdli.org/conferences/conference-pages/the-intersecting-worlds-of-drug-device-biologics-and-health-law. |
Staff NewsElaine Messa, Executive Vice President, Medical Device Practice, Becker Consulting, will be co-chairing the Ninth Annual Medical Device Quality Congress, May 16-18, 2012. The Congress includes presentations by both current FDA officials as well as industry leaders, and will focus on the five areas where FDA targets its enforcement.Congress Website |
Becker Daily Dose - May 18, 2012Yesterday, FDA approved the first generic versions of Plavix (clopidogrel bisulfate), used to reduce the risk of heart attack and stroke be reducing the likelihood of arterial clots caused by blood platelet coagulation. Clopidogrel is intended for patients who have suffered a recent heart attack, stroke, or have peripheral artery disease, and Dr. Keith Webber, Deputy Director of the Office of Pharmaceutical Science in FDA’s Center for Drug Evaluation and Research (CDER), commented that generic products will expand treatment options for these patients and emphasized the importance of having effective and affordable treatment options available.Read More |
Becker Consulting - FDLI Diamond SponsorBECKER CONSULTING is pleased to be a Diamond Sponsor at The Food and Drug Law Institute (FDLI) Annual Conference, being held April 24-25, 2012 at the Ronald Reagan Building/International Trade Center in Washington, DC. We look forward to seeing all of our Daily Dose readers who will be attending the conference at our booth in the exhibit hall. |
Becker & Associates Consulting, Inc. Welcomes Six Leading ExpertsBecker & Associates Consulting, Inc. is proud to announce the newest members and affiliates of the BECKER CONSULTING team:• Mary Getz, PhD – Director of Quality Systems, Medical Device Practice • Larry Schum – Principal Consultant • Carrie Neuberger – Director of European Strategies • Merry Lee Bain – Regulatory Expert We are also excited to welcome two members of our Expert Advisory Committee as full expert consultants on the Becker team: • Tim Ulatowski – Compliance Expert; Regulatory Expert • Wally Pellerite – Compliance Expert |
Becker Daily Dose - May 14, 2012Regulators are being urged by industry to make patient safety a “non-negotiable priority” as biosimilar medicines are being brought to market with the idea that by putting patients first, sound policy will follow. Industry has suggested that FDA needs to conduct a communications campaign about biologics and biosimilars to clearly communicate to all stakeholders what biosimilars are, and the arrival of biosimilars in the US market will increase the challenge and importance of accurate tracking and tracing calling for a more robust system.Read More |
Staff NewsRon Ginor, MD, Chief Executive Officer of BECKER CONSULTING, will be presenting at the first Seminar on Innovation and Invention in the Neurosciences at the American Association of Neurological Surgeons (AANS) Annual Meeting on Sunday, April 15, in Miami, FL. Dr. Ginor will speak at 10:45AM ET about the role of the regulatory pathway and building value for innovative products.AANS Annual Meeting |
Becker Daily Dose - May 9, 2012Yesterday, FDA’s Arthritis Advisory Committee voted 11 to 0 against approval of Regeneron’s Arcalyst, an interleukin-1 blocker for the prevention of gout flares during uric-acid lowering therapy. The committee members voted 9 to 2 that the safety data and 6 to 5 that the efficacy data did not support approval, with some panel members noting that they were not comfortable recommending FDA approval of the product because this drug is expected to be used in high-risk populations which were not represented in the clinical trial.Read More |
Staff NewsAndy Papas, PhD, Director of Regulatory Affairs for the Pharmaceuticals and Biologics Practice at BECKER CONSULTING, and Daniel Kracov, Partner and Head of the FDA and Healthcare Regulatory Practice Group at Arnold & Porter LLP, will be leading a webinar for BioWorld entitled, “Critical Industry Update: Biosimilar Product Development.” Dr. Papas and Mr. Kracov will address key developments in the regulatory landscape for biosimilar products, specifically discussing important topics contained in recently released FDA guidance documents related to biosimilars, as well as considering other important issues for the biotechnology industry. This interactive webinar will be held next Wednesday, April 18, 2012 from 2-3:30 PM ET, and details on how to join the conference can be found here.BioWorld Webinar |
Join Our TeamBecker & Associates, Inc. is looking for skilled compliance and regulatory experts to join our team on a contract basis. Do you have FDA and/or industry experience with medical device, pharmaceutical, or biologics regulation and compliance? Please use the link below to learn more and to contact us regarding the positions available. We look forward to hearing from youContract-Based Employment at Becker & Associates, Inc. |
Grand Rounds with Tim UlatowskiTim Ulatowski, former Director of the Office of Compliance at FDA's Center for Devices and Radiological Health, spoke at Becker Consulting this afternoon regarding his background and experiences at FDA over his 36 year career with the agency. Included was a discussion of the interactions between the Offices of Device Evaluation and Compliance, current FDA trends, initiatives, and enforcement actions. Mr. Ulatowski now serves as a Director on the Becker Consulting Expert Advisory Committee. |
Becker 2012 Team KickoffLooking forward to working together with you to make 2012 a productive and successful year.Full Image |
Staff NewsHarold "Wally" Pellerite, Director of the Medical Device Compliance Committee at Becker Consulting, will speak on a panel during the “Enforcement, Litigation and Compliance Conference” held by the Food and Drug Law Institute (FDLI) on December 6-7, 2011, at the Westin Georgetown in Washington, DC. Mr. Pellerite will be discussing quality and recall issues during the December 6 afternoon panel on “Medical Product Safety.”Conference Information |
Staff NewsRon Ginor, MD, Chief Executive Officer of Becker Consulting, spoke on a panel during the “Issues in Global Health: Advancing Efficiency and Quality through Regulatory Science” symposium sponsored by the Johns Hopkins Carey Business School and the Food and Drug Law Institute (FDLI) on December 2, 2011, at the National Press Club in Washington, DC. Dr. Ginor used case studies and recent examples to speak to the regulatory realities facing manufacturers and affecting public health officials during the second morning panel on “Realities of Global Compliance.”JHU News Release Symposium Information |
Press ReleaseBecker & Associates Consulting, Inc. (Becker Consulting) is proud to announce the addition of Tim Ulatowski, former Director of the Office of Compliance within the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA), as Director, Medical Devices on the Becker Consulting Expert Advisory Committee. Mr. Ulatowski has over 36 years of public health experience, including more than 25 years in multiple leadership positions at FDA’s CDRH.Press Release |
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