FDA commissioner to drug middlemen: You're part of the problem (CNBC) (Speech)
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Trayt debuts mobile app to track and help treat autism, ADHD (Fierce)
FDA approves heart monitor unanimously rejected by expert panel in 2016 (Fierce)
FDA Action Plan Promotes Innovation to Make Medical Devices Safer (AAMI)
Valeritas taps Glooko’s data management platform for next-gen insulin delivery device (MassDevice) (Press)
FDA OKs Opus breast implant line from Sientra (MassDevice) (Press)
Abbott releases firmware patch to fix cybersecurity flaws in 350,000 medical devices (Healthcare IT News)
AdvaMed Applauds Summit of the Americas' Focus On Importance of Business Ethics and Good Regulatory Practices (AdvaMed)
QIAGEN Announces FDA Approval of PartoSureTM (Press)
Women Treated with Hologic's NovaSure Endometrial Ablation System in New Study Reported Higher Amenorrhea Rates than Those Treated with Minerva (Press)
New Study Investigates the Utility of Masimo SpHb in Post-operative Red Blood Cell (RBC) Transfusion Best Practices (Press)
BD Unveils Suite of Diagnostic Informatics and Automation Innovations (Press)
US: Assorted & Government
U.S. appeals court blocks Indiana 'selective' abortion law (Reuters)
Spectrum of Diseases by Therapeutic Area found in Written Requests as of March 31, 2018 (FDA)
Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 17-19 April 2018: CVMP adopts new guideline on user safety of topically applied veterinary medicines (EMA)
Eye injuries in people and dogs when using Osurnia ear gel for dogs: Caution is advised when applying the medicine (EMA)
Civil Society representatives: Call for expressions of interest is open for the EMA Management Board (EC)
QIAGEN announces European launch of QIAstat-Dx, a next generation platform for syndromic insights (Press)
Asia
Large spleen helps explain deep-diving skills of Southeast Asian 'sea nomads' (Reuters)
Chinese investor group acquires Esaote (MassDevice)
Hong Kong clears way for pre-revenue biotech IPOs, plans to accept listing applications by May (Endpoints)
Glaxo has to face lawsuit by Armenians who couldn’t decipher Avandia warnings (STAT-$)
MHLW Sees Solid Inquiry Numbers for Conditional Early Approval System: Official (Pharma Japan)
Vaxart Announces $5 Million Inavir Revenue Milestone (Press)
Q3 Medical Devices Ltd. and the Boill Group Continue Expansion Plans in China (Press)
India
India can lead the way to deliver health for all (Hindustan Times)
Analysis Why prosecuting Indian pharma patents could be even more difficult than it appears (IAM-$)
Health Canada should stop approving homeopathic remedies — period: Robyn Urback (CBC News)
Good economics and good health: How Canada’s pharmaceutical companies make an impact (National Post)
Sunovion Announces Health Canada Approval of Latuda (lurasidone HCl) to Treat Adolescents (13 to 17 years of age) with Bipolar Depression (Press)
Indivior Announces New Drug Submission to Health Canada for SUBLOCADE (Buprenorphine Extended-Release) Injection for the Treatment of Moderate to Severe Opioid Use Disorder (Press)
General Health & Other Interesting Articles
Concussion raises Parkinson's disease risk in large U.S. study (Reuters)
Early Skin Cancer is More Accurately Diagnosed by a Dermatologist Than Other Providers, New Research Shows (UPMC) (JAMA)
Barbara Bush Leaves A Legacy: Champion For End-Of-Life Care (Forbes)
Trayt's new app to help people with neurodevelopmental disorders track symptoms (Mobihealthnews)
Treating pain without addiction: inside the lab fighting the opioid crisis (The Guardian)
Consumers Are Getting Conflicting Advice on Romaine Lettuce Safety Amid the Mysterious E. Coli Outbreak (Fortune)
The next generation of doctors may be learning bad habits at teaching hospitals with many safety violations (STAT)
3 ways to expand access to mental health care beyond adding more psychiatrists (STAT)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work. Need to contact the editor of Regulatory Reconnaissance? Email us at [email protected]. A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.
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