FDA fast-tracks TapImmune's ovarian cancer drug study | Thiel associate Srinivasan reportedly considered for FDA chief | FDA publishes guidances on drug and biologics repackaging, mixing, diluting
January 17, 2017
FDLI SmartBrief
News for the food and drug law community
Drugs & Biologics
FDA fast-tracks TapImmune's ovarian cancer drug study
The FDA has granted fast-track designation to TapImmune's double-blind placebo study that will assess its T-cell therapy TPIV 200 as a treatment for platinum-sensitive ovarian cancer in combination with chemotherapy. Three clinical sites have been approved to start patient enrollment.
The Business Journals (tiered subscription model)/Jacksonville, Fla. (1/16) 
Thiel associate Srinivasan reportedly considered for FDA chief
Former biotech executive Balaji Srinivasan, an associate of venture capitalist Peter Thiel, is under consideration by President-elect Donald Trump to head the FDA, sources say. Srinivasan has been critical of the FDA, saying it has slowed scientific innovation.
Bloomberg (1/13),  The Hindu (India) (1/17) 
FDA publishes guidances on drug and biologics repackaging, mixing, diluting
The FDA has issued its final guidance on repackaging drugs, which clarifies the agency's definition of repackaging and lists situations in which regulations would not be applied, such as when repackaging is done by federal facilities, state-licensed pharmacies or registered outsourcing facilities that meet the guidance's criteria. Meanwhile, a draft guidance has also been released by the agency regarding diluting, mixing and repackaging of biologics, stating that when such actions are done outside the scope of an approved biologics license application, the biological product would be considered unlicensed.
Regulatory Focus (1/16) 
Power Dynamics Make You More Persuasive
How powerful you feel affects what you say, and what you want to hear. Learn more from research by Kellogg School of Management Professor Derek Rucker.
Global Focus
European drug associations urge consistent regulations after Brexit
The European Federation of Pharmaceutical Industries and Associations and the Association of the British Pharmaceutical Industry urged UK regulators to keep post-Brexit approval and safety laws consistent with those of the European Union.
InPharm.com (1/17) 
NICE announces delay to planned charges for device, drug appraisals
Plans to charge medical device, diagnostics and pharmaceutical companies fees of up to approximately $349,000 for every cost-effectiveness assessment has been postponed by the UK's National Institute of Health and Care Excellence until completion of the new UK government's life sciences strategy. "We have been working to create a new funding model for technology evaluation to meet the government's challenge to drive efficiency and deliver better value," said Sir Andrew Dillon, chief executive of NICE.
Regulatory Focus (1/16) 
2 Indian firms to be sued by state regulator after faking purchase invoices
Nashik, India-based wholesalers Karwa Pharmaceuticals and Choudhary & Co. will be prosecuted by the Maharashtra FDA for procuring and stocking drugs without the correct purchase documents, which violates the country's Drugs and Cosmetics Act. The investigation showed that the wholesalers colluded with medical representatives and a drugmaker to purchase drugs at a discount using a fake purchase invoice meant for government hospitals and then stocked the drugs in medical stores.
PharmaBiz.com (India) (1/13) 
Food & Dietary Supplements
Undeclared allergen causes recall of potato chips
Some bags of Hot Thin & Crispy Potato Chips are being recalled by Alabama-based Golden Flake Snack Foods due to the undeclared presence of milk. The products affected by the recall come in 5-ounce bags with a "best if used by" date of April 14, 2017, and have the product code Lot 364 5 or 365 5.
Food Poisoning Bulletin (1/16) 
Medical Devices
Study of Boston Scientific's heart device approved by CMS
Boston Scientific has obtained approval from the CMS for a randomized study of its Watchman left atrial appendage closure device. The post-FDA approval, 888-patient trial seeks to assess the safety and efficacy of the device in treating patients with nonvalvular atrial fibrillation who cannot take oral anticoagulants.
CardiovascularBusiness.com (1/16) 
Safe Orthopaedics announces European launch of cervical cage bone substitute
A bone substitute has been launched in Europe by French medtech firm Safe Orthopaedics for its Walnut cervical cage. The company developed the device in partnership with a synthetic bone substitute specialist to allow for safer vertebral fusion and promote bone growth.
Medical Devices Business Review (U.K.) (1/16) 
FDLI Items
Taking place in April: Introduction to U.S. Medical Device Law and Regulation
Explore the essentials of device law and regulation and gain a comprehensive understanding of the administrative agencies that affect this industry. Learn about registration and listing procedures, elements of conducting clinical investigations, the premarket approval application and related issues. Learn more.
FDCA Statutory Supplement, 2017: Reserve your copy today
Updated to incorporate the 21st Century Cures Act, FDCA Statutory Supplement, 2017 is an indispensable tool for FDA law practitioners. This publication provides cross-referencing of the numerous legislative amendments to the original statute, facilitating quick research and citation, and highlights recent changes. Order today.
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