d Former California Attorney Sentenced to 60 Months for His Role in International Investment Fraud Scheme By www.justice.gov Published On :: Tue, 23 Feb 2016 20:45:29 EST A Las Vegas man was sentenced today to 60 months in prison for his role in an investment fraud scheme that promoted fraudulent investment opportunities and caused more than $5 million in losses to investors Full Article OPA Press Releases
d Former Postal Clerk Pleads Guilty to Stealing Mail By www.justice.gov Published On :: Wed, 23 Mar 2016 20:45:27 EDT NORFOLK, Va Full Article OPA Press Releases
d New York Man Pleads Guilty to Conspiracy to Defraud U.S. Defense Contractors By www.justice.gov Published On :: Tue, 29 Mar 2016 20:45:42 EDT ALEXANDRIA, Va Full Article OPA Press Releases
d Norfolk Man Sentenced to Prison for Mail and Wire Fraud By www.justice.gov Published On :: Thu, 28 Apr 2016 20:45:25 EDT NEWPORT NEWS, Va Full Article OPA Press Releases
d Former Fox News Commentator Pleads Guilty to Fraud By www.justice.gov Published On :: Mon, 2 May 2016 08:45:35 EDT ALEXANDRIA, Va Full Article OPA Press Releases
d Former SunTrust Mortgage VP and Loan Officers Sentenced to Prison By www.justice.gov Published On :: Mon, 2 May 2016 08:45:35 EDT ALEXANDRIA, Va Full Article OPA Press Releases
d Alexandria Adult Day Healthcare Center Settles Civil Fraud Allegations By www.justice.gov Published On :: Wed, 4 May 2016 08:45:24 EDT ALEXANDRIA, Va Full Article OPA Press Releases
d Former Postal Worker Sentenced to Prison for Workers’ Comp Fraud By www.justice.gov Published On :: Thu, 5 May 2016 08:45:25 EDT NORFOLK, Va Full Article OPA Press Releases
d Navy Senior Chief Indicted in ID Theft and Bank Fraud Scheme By www.justice.gov Published On :: Thu, 5 May 2016 20:45:25 EDT NORFOLK, Va Full Article OPA Press Releases
d Two Former Deutsche Bank Employees Indicted on Fraud Charges in Connection with Long-Running Manipulation of Libor By www.justice.gov Published On :: Thu, 2 Jun 2016 14:45:33 EDT Two former Deutsche Bank AG (Deutsche Bank) traders—the bank’s supervisor of the Pool Trading Desk in New York and a derivatives trader in London—were indicted for their alleged roles in a scheme to manipulate the U Full Article OPA Press Releases
d Former Director of General Services Administration Division and Husband Indicted for Fraud and Nepotism By www.justice.gov Published On :: Wed, 15 Jun 2016 14:45:25 EDT ALEXANDRIA, Va Full Article OPA Press Releases
d Three Men Sentenced to Prison for Credit Card Fraud Scheme By www.justice.gov Published On :: Fri, 17 Jun 2016 11:45:50 EDT RICHMOND, Va Full Article OPA Press Releases
d Former Loudoun County Sheriff’s Deputy Sentenced to Prison By www.justice.gov Published On :: Fri, 17 Jun 2016 20:45:22 EDT ALEXANDRIA, Va Full Article OPA Press Releases
d Toano Man Pleads Guilty to Impersonating a Federal Agent By www.justice.gov Published On :: Fri, 24 Jun 2016 20:45:27 EDT NEWPORT NEWS, Va Full Article OPA Press Releases
d Former Nurse Pleads Guilty to ID Theft and Bank Fraud By www.justice.gov Published On :: Fri, 24 Jun 2016 20:45:27 EDT RICHMOND, Va Full Article OPA Press Releases
d New FDA guidance on alternate approaches in premarket notification for Class II medical devices By feedproxy.google.com Published On :: Fri, 20 Dec 2019 14:09:57 +0000 By Alice Li, MD, MSc, RAC (CAN), Regulatory Scientist, Cato Research FDA issued “The Abbreviated 510(k) Program – Guidance for Industry and Food and Drug Administration Staff” on 13 September 2019. The content of this guidance supersedes the content from 1998 guidance “The New 510(k) Paradigm – Alternate Approaches to Demonstrating Substantial Equivalence in Premarket … Continue reading » Full Article Cato Research FDA FDA Regulatory Guidances Medical Device FDA Guidances medical devices
d What’s New Health Canada? November 2019 Updates By feedproxy.google.com Published On :: Fri, 20 Dec 2019 14:41:48 +0000 By Alejandra Gomez Perez, M.Sc., Regulatory Affairs Associate What’s New in: Therapeutic Products Directorate: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/what-new-drug-products-health-canada.html Biologics and Genetic Therapies Directorate: http://www.hc-sc.gc.ca/dhp-mps/brgtherap/update-miseajour/index-eng.php Medical Devices: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/what-new.html Natural and Non-prescription Health Products Directorate: https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/what-new.html Updates from Health Canada Type of Update and Link Date Posted Notice – Update to Clinical Trial Site Information Form 29 November … Continue reading » Full Article Canadian Regulatory Affairs Cato Research Health Canada regulatory
d New FDA Guidances for November and December 2019 and Upcoming Advisory Committee Meetings By feedproxy.google.com Published On :: Mon, 06 Jan 2020 21:36:51 +0000 By Alice Li, MD, MSc, RAC(CAN), Regulatory Scientist, Cato Research Special Interest Guidances/Information Date Posted Guidance for Industry: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion, Reference Amounts Customarily Consumed, Serving Size-Related Issues, Dual-Column Labeling, and Miscellaneous Topics – Final Guidance 30 Dec 2019 Submission of Plans for Cigarette Packages … Continue reading » Full Article FDA Regulatory Guidances FDA Guidances
d New FDA Gudiances for January 2020 and Upcoming Advisory Committee Meetings By feedproxy.google.com Published On :: Tue, 04 Feb 2020 20:21:28 +0000 By Sheila Plant, PhD, MHS, RAC, Senior Director, Regulatory Strategy, CATO SMS Special Interest Guidances/Information Date Posted Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components; Draft Guidance for Industry: Draft Guidance for Industry – Draft Guidance 30 Jan 2020 Arthroscopy Pump Tubing Sets … Continue reading » Full Article FDA FDA Regulatory Guidances Rare Diseases Regulatory Affairs Cato Research FDA Guidances rare diseases
d What’s New Health Canada? January and February 2020 Updates By feedproxy.google.com Published On :: Wed, 04 Mar 2020 17:52:44 +0000 By Alejandra Gomez Perez, M.Sc., Regulatory Affairs Associate What’s New in: Therapeutic Products Directorate: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/what-new-drug-products-health-canada.html Biologics and Genetic Therapies Directorate: http://www.hc-sc.gc.ca/dhp-mps/brgtherap/update-miseajour/index-eng.php Medical Devices: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/what-new.html Natural and Non-prescription Health Products Directorate: https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/what-new.html Updates from Health Canada Type of Update and Link Date Posted Notice: Product Monograph Implementation Plans 13 January 2020 … Continue reading » Full Article Health Canada Updates Health Canada Regulatory Authorities
d New FDA Gudiances for February 2020 and Upcoming Advisory Committee Meetings By feedproxy.google.com Published On :: Wed, 04 Mar 2020 18:28:34 +0000 By Sheila Plant, PhD, MHS, RAC, Senior Director, Regulatory Strategy, CATO SMS Special Interest Guidances/Information Date Posted Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency: Immediately in Effect Guidance for Clinical Laboratories and Food and … Continue reading » Full Article FDA Regulatory Guidances CATOSMS FDA FDA Guidances Regulatory Authorities
d New FDA Gudiances for March 2020 and Upcoming Advisory Committee Meetings By feedproxy.google.com Published On :: Mon, 06 Apr 2020 20:00:27 +0000 By Sheila Plant, PhD, MHS, RAC, Senior Director, Regulatory Strategy, CATO SMS FDA guidances from March 2020 as well as upcoming advisory committee meeting announcements are below. We note that approximately one-third of FDA’s guidances this past month are related to COVID-19. Special Interest Guidances/Information Date Posted Enforcement Policy for Gowns, Other Apparel, and … Continue reading » Full Article FDA Regulatory Guidances Cato Research FDA FDA Guidances
d Consideration for ongoing clinical trials: Ensuring Participant Safety and Adapting New Processes during COVID‑19 Pandemic By feedproxy.google.com Published On :: Wed, 29 Apr 2020 13:00:12 +0000 By Ashley Henderson, PhD, CATO SMS Scientist 1.0 INTRODUCTION The COVID‑19 pandemic has added an unprecedented set of challenges to the conduct of clinical trials including quarantines, travel limitations, site closures, and interruptions in the supply chain of investigational products. In acknowledgement of these challenges, the Food and Drug Administration (FDA) recognizes that protocol modifications … Continue reading » Full Article Clinical Trials CATOSMS COVID-19
d New FDA Gudiances for April 2020 and Upcoming Advisory Committee Meetings By feedproxy.google.com Published On :: Fri, 01 May 2020 21:21:17 +0000 By Zachary Swan, PhD, RAC, Associate Director, Regulatory Affairs at CATO SMS Special Interest Guidances/Information Date Posted Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency: Guidance for Industry – Final Guidance 30 April 2020 FDA Deems Certain Tobacco Products Subject to FDA Authority, … Continue reading » Full Article FDA Regulatory Guidances CATO SMS FDA Guidances
d What’s New Health Canada? By feedproxy.google.com Published On :: Thu, 07 May 2020 21:44:25 +0000 By Alejandra Gomez Perez, M.Sc., Regulatory Affairs Associate What’s New in: Therapeutic Products Directorate: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/what-new-drug-products-health-canada.html Biologics and Genetic Therapies Directorate: http://www.hc-sc.gc.ca/dhp-mps/brgtherap/update-miseajour/index-eng.php Medical Devices: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/what-new.html Natural and Non-prescription Health Products Directorate: https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/what-new.html Updates from Health Canada New Private Label Medical Device Licence Application Form 07 April 2020 Guidance Document: How to Complete the … Continue reading » Full Article Canadian Regulatory Affairs Cato Research Health Canada CATOSMS
d Shot Roster: COVID-19 Vaccines In Human Trials By www.rttnews.com Published On :: Fri, 01 May 2020 00:58:48 GMT The ongoing COVID-19 pandemic has sickened over 3.25 million people and has killed 233,014 people, according to data from Johns Hopkins University. Full Article
d FDA Approves NASA-Developed Ventilator For Emergency Use By www.rttnews.com Published On :: Fri, 01 May 2020 09:51:13 GMT The U.S. Food and Drug Administration approved a new high-pressure ventilator developed by NASA to treat coronavirus or COVID-19 patients. The space agency is offering the designs for licensing on a royalty-free basis during the time of the pandemic, hoping to increase the availability of life-saving medical devices. Full Article
d SAVA Gets Funding For AD Drug, JNJ Hits All-time High, ENZ On Watch By www.rttnews.com Published On :: Fri, 24 Apr 2020 05:43:19 GMT Today's Daily Dose brings you news about Cassava Sciences' research grant from the National Institutes of Health for developing Alzheimer's disease drug; Edwards Lifesciences' Q1 financial results; Enzo Biochem's launch of the next-generation COVID-19 test kits and Johnson & Johnson's deal with Emergent BioSolutions related to COVID-19 Vaccine candidate. Full Article
d Vir Biotechnology, Alnylam Identify VIR-2703 Candidate For Treatment Of COVID-19 By www.rttnews.com Published On :: Mon, 04 May 2020 11:51:31 GMT Vir Biotechnology, Inc. (VIR) and Alnylam Pharmaceuticals, Inc. (ALNY) announced Monday that they have selected a development candidate (DC) for VIR-2703 (ALN-COV), an investigational RNAi therapeutic targeting the SARS-CoV-2 (COVID-19) genome. Full Article
d Lupin Pharma: Phase 3 Trial Of Single-Dose Solosec Met Primary Endpoint By www.rttnews.com Published On :: Mon, 04 May 2020 11:56:29 GMT Lupin Pharmaceuticals Inc. (LUPIN, 500257) on Monday announced positive top-line results from its pivotal Phase 3 clinical trial to assess the efficacy and safety of single-dose Solosec or secnidazole 2g oral granules in 147 female patients with trichomoniasis. Full Article
d Junshi, Eli Lilly Agree To Co-develop JS016 Antibodies Against COVID-19 By www.rttnews.com Published On :: Mon, 04 May 2020 12:38:58 GMT Junshi Biosciences, a China-based biopharmaceutical company, and Eli Lilly and Company (LLY) have entered into an agreement to co-develop therapeutic antibodies for the potential prevention and treatment of COVID-19. Junshi SARS-CoV-2 Antibodies, or JS016, is a recombinant fully human monoclonal neutralizing antibody that is specific to the SARS-CoV-2 surface spike protein receptor binding domain. It is jointly developed by Junshi Biosciences and Institute of Microbiology, Chinese Academy of Science. Full Article
d Axsome Therapeutics (AXSM) Advances To Cross $100-Mark By www.rttnews.com Published On :: Mon, 27 Apr 2020 10:45:29 GMT Axsome Therapeutics Inc.'s (AXSM) phase II/III trial of investigational drug AXS-05 in Alzheimer's disease agitation has met the primary endpoint. Full Article
d Sutro Biopharma Reports Updated Data From Ovarian Cancer Study By www.rttnews.com Published On :: Mon, 27 Apr 2020 11:35:52 GMT Sutro Biopharma Inc.'s (STRO) interim phase I updated clinical data for a dose-escalation study of antibody drug-conjugate STRO-002 in ovarian cancer has been encouraging. Full Article
d RedHill Biopharma Provides Update On Compassionate Use Program With Opaganib By www.rttnews.com Published On :: Mon, 27 Apr 2020 11:37:16 GMT Biopharmaceutical company RedHill Biopharma Ltd. (RDHL) on Monday provided an additional update on the compassionate use program with its investigational drug, opaganib (Yeliva, ABC294640)1, in patients with confirmed SARS-CoV-2 infection (the cause of COVID-19) in Israel. Full Article
d Avadel (AVDL) Soars On REST-ON Trial Results By www.rttnews.com Published On :: Mon, 27 Apr 2020 12:11:18 GMT Avadel Pharmaceuticals plc's (AVDL) pivotal phase III trial evaluating FT218 for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy has met its three co-primary efficacy endpoints at all three doses. Full Article
d FDA Warns Of Risks Related To Use Of Anti-malaria Drugs For COVID-19 By www.rttnews.com Published On :: Mon, 27 Apr 2020 13:03:03 GMT Though it issued an Emergency Use Authorization (EUA) for anti-malaria drugs to treat or prevent coronavirus (COVID-19), the U.S. Food and Drug Administration (FDA) reiterated its warning about the known side effects of hydroxychloroquine and chloroquine, including serious and potentially life-threatening heart rhythm problems. Full Article
d Gilead's Remdesivir Becomes 1st Drug Allowed For Emergency Use For COVID-19 By www.rttnews.com Published On :: Sat, 02 May 2020 02:41:07 GMT The FDA has issued emergency use authorization for Gilead Science Inc's (GILD) antiviral drug Remdesivir for the treatment of COVID-19 in adults and children hospitalized with severe disease. Full Article
d FDA Decision On BMY's Drug Postponed, ENTA's PBC Study Fails, MGNX Turns Heads By www.rttnews.com Published On :: Thu, 07 May 2020 03:33:38 GMT Today's Daily Dose brings you news about the revised FDA decision date for Bristol Myers' CAR T cell therapy for refractory large B-cell lymphoma; Enanta Pharma's primary biliary cholangitis trial results; MacroGenics' anticipated clinical data read-outs and regulatory event for this year and Trovagene's name change. Full Article
d IMMU Gets Early FDA Nod, KNSA's PN Trial Meets Goals, MYOV In Good Spirits By www.rttnews.com Published On :: Thu, 23 Apr 2020 06:16:08 GMT Today's Daily Dose brings you news about FDA approval of Immunomedics' breast cancer drug; promising results from Kiniksa Pharma's prurigo nodularis trial; Mallinckrodt's regulatory catalyst; Myovant Sciences' phase III SPIRIT 2 study results and another disappointment in Parkinson's disease drug development space. Full Article
d Ocean Spray Recalls Pink Lite Cranberry Juice For Undeclared Sulfites By www.rttnews.com Published On :: Thu, 23 Apr 2020 11:43:59 GMT Ocean Spray Cranberries, Inc. is recalling Pink Lite Cranberry Juice Drink citing potential for undeclared sulfites, the U.S. Food and Drug Administration said in a statement. The recall involves a single production lot of 5.5oz cans of the drink with lot number MH0030LPK4 and Best Before Date of 24JAN21. The product is sold in boxes containing six 5.5oz cans. They were distributed to retail Full Article
d FDA Gives Nod To Medtronic's Hemodialysis Device For Pediatric Patients By www.rttnews.com Published On :: Thu, 30 Apr 2020 12:15:55 GMT The U.S. Food and Drug Administration granted marketing authorization to Medtronic Inc.'s CARPEDIEM System, a new device for continuous dialysis therapy for use in pediatric patients with certain kidney conditions. The system is indicated to provide continuous hemodialysis or hemofiltration therapy to critically ill pediatric patients weighing between 2.5 and 10 kilograms. Full Article
d Medifast Recalls Optavia Oatmeal For Undeclared Milk By www.rttnews.com Published On :: Tue, 05 May 2020 11:38:17 GMT Baltimore, Maryland-based Medifast, Inc. is recalling certain Optavia Oatmeal products citing undeclared milk, a known allergen, the U.S. Food and Drug Administration said in a statement. The recall involves around 24,923 boxes of OPTAVIA Essential Old Fashioned Maple & Brown Sugar Oatmeal. The product is packaged in yellow and white cardboard boxes with the brand name. Full Article
d FDA Clears 1st Product Derived From Amniotic Fluid To Enter COVID-19 Trial By www.rttnews.com Published On :: Tue, 05 May 2020 13:21:37 GMT Organicell Regenerative Medicine Inc. (BPSR.OB) has received FDA clearance to initiate a phase I/II multi-center clinical trial of Organicell Flow in patients diagnosed with moderate to severe acute respiratory syndrome (SARS) due to COVID-19 infection. Full Article
d CYCC In STOPCOVID, EXEL Hits New High, NVS Trialing Malaria Drug For COVID-19 By www.rttnews.com Published On :: Tue, 21 Apr 2020 05:39:42 GMT Today's Daily Dose brings you news about Bristol-Myers' CheckMate -743 study results; Cyclacel Pharma's entry into COVID-19 drug bandwagon; Exelixis touching a new 52-week high and Novartis exploring anti-malaria drug for COVID-19. Full Article
d LabCorp's COVID-19 At-Home Test Kit Receives EUA From FDA - Quick Facts By www.rttnews.com Published On :: Tue, 21 Apr 2020 11:06:05 GMT Life sciences company LabCorp (LH) announced Tuesday that it has received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its COVID-19 at-home test kit. Full Article
d Biotech Stocks Facing FDA Decision In May 2020 By www.rttnews.com Published On :: Tue, 28 Apr 2020 02:29:38 GMT So far this year, 16 novel drugs have received FDA approval compared to 9 which were greenlighted during the same period last year. Now, let's take a look at the biotech stocks that are awaiting a regulatory decision in May 2020. Full Article
d Relmada Therapeutics (RLMD): Sending The Right Signals? By www.rttnews.com Published On :: Tue, 28 Apr 2020 10:46:01 GMT Shares of Relmada Therapeutics Inc. (RLMD) have gained 19 percent so far this year and trade around $37. Full Article
d ARDS In COVID-19 Battle, AKBA's Kidney Disease Drug Hits Goals, VAPO On A Roll By www.rttnews.com Published On :: Wed, 06 May 2020 05:15:35 GMT Today's Daily Dose brings you news about the acquisition of Portola by Alexion; encouraging results from TG Therapeutics' chronic lymphocytic leukemia trial; Akebia's INNO2VATE trial results; and Vapotherm's Q1 financial results. Full Article
d Israel-based Ayala Pharma To Debut On Nasdaq On May 7 By www.rttnews.com Published On :: Wed, 06 May 2020 11:47:24 GMT Israel-based Ayala Pharmaceuticals is slated to debut on the Nasdaq Global Select Market, under the symbol 'AYLA', on May 7, 2020. Full Article
d LIFE In COVID-19 Battle, LH On Watch, CARA Keeps KALM, All Eyes On MYOV By www.rttnews.com Published On :: Wed, 22 Apr 2020 04:56:54 GMT Today's Daily Dose brings you news about aTyr Pharma joining the COVID-19 battle; Cara's pivotal KALM-2 trial; LabCorp's at-home collection kit for COVID-19 testing securing Emergency Use Authorization from the FDA, and Myovant's much-awaited clinical trial catalyst. Full Article
