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Trump FY 2018 Budget Blueprint: Hike in FDA User Fees? By Zachary Brennan - Published 16 March 2017

President Donald Trump’s administration released its budget blueprint for FY 2018 on Thursday, calling for a hike in user fees from industry to make up for cuts elsewhere at the US Food and Drug Administration (FDA).

Categories: News, US, DOJ, FDA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Trump budget, FDA budget 2018, user fees, user fee reauthorization

Regulatory Recon: Alexion to Lay Off More Than 200; FDA Approves Novartis Breast Cancer Treatment (14 March 2017) By Zachary Brennan - Published 14 March 2017

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing.

Categories: News, Asia, Canada, Europe, US, DOJ, EC, EMA, FDA, Health Canada, MHRA, NICE, Biologics and biotechnology, Drugs, In vitro diagnostics, Medical Devices

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

21st Century Cures Act Deadlines Approach in March and June By Zachary Brennan - Published 22 February 2017

The massive 21st Century Cures Act, rushed to passage in the waning days of President Barack Obama’s presidency, features a whole host of provisions that will take years for the US Food and Drug Administration (FDA) and National Institutes of Health (NIH) to digest and implement, but it also includes several provisions that must be addressed by 13 March.

Categories: News, US, DOJ, FDA, Biologics and biotechnology, Clinical, Drugs, Government affairs, Medical Devices

Tags: 21st Century Cures, Cures Act, NIH and Cures, clinicaltrials.gov, patient experience data and FDA

FDA, DOJ Investigate Galena Biopharma’s Former Promotions of Fentanyl By Zachary Brennan - Published 09 January 2017

Galena Biopharma on Monday disclosed in an SEC filing that the US Attorney’s Office for the District of New Jersey and the US Department of Justice (DOJ) are pursuing a criminal investigation, in addition to a previously announced civil investigation, related to the marketing and promotion of its deadly opioid Abstral (fentanyl), which the company sold for $8 million upfront in 2015.

Categories: News, US, DOJ, FDA, Advertising and Promotion, Drugs, Regulatory intelligence

Tags: Galena, DOJ, Abstral, fentanyl marketing

Regulatory Recon: Teva Settles Foreign Bribery Charges for $519M; Former HHS Officials on Trump’s Pick for HHS (22 December 2016) By Zachary Brennan - Published 22 December 2016

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @RAPSorg on Twitter.

Categories: News, Europe, US, DOJ, EC, EMA, FDA, MHRA, NICE, Biologics and biotechnology, Drugs, Medical Devices

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Former Insys Executives Arrested on Racketeering Charges By Michael Mezher - Published 08 December 2016

Six former Insys Therapeutics executives and managers were arrested on Thursday on charges that they conspired to bribe healthcare practitioners to prescribe the company's fast-acting fentanyl spray Subsys.

Categories: News, US, DOJ, Drugs

Tags: Insys, Department of Justice, Kickbacks, Subsys, Opioid Epidemic

Regulatory Recon: CRISPR Gene Editing Tested in First Person; Republicans Tell US Federal Agencies to Stop Work on Regulations Until Trump Takes Office (16 November 2016) By Zachary Brennan - Published 16 November 2016

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @RAPSorg on Twitter.

Categories: News, Africa, Asia, Canada, Europe, Latin America and Caribbean, Middle East, Oceania, US, DOJ, EMA, FDA, FTC, MHRA, NICE, PMDA, TGA, Biologics and biotechnology, Business and Leadership, Clinical, Drugs, Government affairs, Medical Devices, Quality, Regulatory intelligence, Regulatory strategy

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Medical Device Manufacturer Pleads Guilty to Misbranding and Agrees to Pay $36M By Zachary Brennan - Published 11 November 2016

Pennsylvania-based medical device manufacturer Biocompatibles Inc., a BTG subsidiary, pleaded guilty earlier this week to misbranding its embolic device used to treat liver cancer, among other diseases, and will pay more than $36 million due its illegal conduct, the Justice Department (DOJ) said. 

Categories: News, US, DOJ, FDA, Advertising and Promotion, Crisis management, Government affairs, Medical Devices, Postmarket surveillance, Product withdrawl and retirement, Regulatory intelligence, Regulatory strategy

Tags: Biocompatibles, misbranded medical devices, drug delivery, chemotherapy, LC Bead, BTG

New Senate Bill Aims to Close Regulatory Loopholes Blocking Generic Drug Competition By Zachary Brennan - Published 15 June 2016

Members of the Senate Judiciary Committee introduced bipartisan legislation on Tuesday that seeks to stop anticompetitive practices brand name drug companies often use to thwart or delay the entry of less-expensive generic versions of their products.

Categories: News, US, DOJ, FDA, FTC, Business and Leadership, Crisis management, Generic drugs, Regulatory intelligence, Regulatory strategy

Tags: generic drug competition, CREATES Act, REMS

FDA, International Authorities Shutter Thousands of Illegal Online Drug Stores By Michael Mezher - Published 09 June 2016

The US Food and Drug Administration (FDA) and other international regulators and law enforcement on Thursday announced the results of a series of actions to combat illegal and counterfeit medicines.

Categories: News, US, DOJ, FDA, Biologics and biotechnology, Distribution, Drugs

Tags: Pangea XI, Interpol, Counterfeit medicines

Pharma Companies Warn of Regulatory ‘Dead Zone’ With FDA’s Interpretation of BPCIA By Zachary Brennan - Published 27 May 2016

Sanofi, Mylan, Novo Nordisk, and industry groups PhRMA and the Biosimilars Council are all calling on the US Food and Drug Administration (FDA) to amend its interpretation of the "deemed to be a license" provision of the Biologics Price Competition and Innovation Act (BPCIA) of 2010 as some are saying the current draft guidance could halt biosimilar development for a prolonged period.

Categories: News, US, DOJ, FDA, Biologics and biotechnology, Compliance, Product withdrawl and retirement

Tags: Sanofi, Mylan, PhRMA, GPhA, biosimilars, BPCIA

‘Truthful and Non-Misleading’: GOP Reps Take Issue With FDA’s Handling of Off-Label Marketing By Zachary Brennan - Published 27 May 2016

The tricky part about the off-label marketing of drugs, or the marketing of drugs to doctors for unapproved indications, is that companies, and not the US Food and Drug Administration (FDA), may get to decide what some courts are referring to as “truthful and non-misleading” marketing information.

Categories: News, US, DOJ, FDA, Biologics and biotechnology, Compliance, Crisis management, Drugs, Labeling, Medical Devices

Tags: off-label marketing, Pacira, Amarin, Vascular Solutions, FDA and drug labels

DOJ: Device Manufacturers Can Relay ‘Truthful’ Info on Unapproved Uses By Zachary Brennan - Published 19 January 2016

A US Department of Justice attorney for the first time explained in a set of jury instructions that it is legal for a device company or its sales representatives to provide doctors with “wholly truthful and non-misleading information” about off-label medical device uses.

Categories: News, US, DOJ, FDA, Advertising and Promotion, Government affairs, Labeling, Medical Devices

Tags: free speech, off-label marketing, Amarin, Caronia, misbranding, off-label medical device uses

Regulatory Recon: Shkreli Arrested on Securities Fraud Charges (17 December 2015) Published 17 December 2015

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

Categories: News, Africa, Asia, Canada, Europe, Latin America and Caribbean, Oceania, US, Anvisa, CDSCO, DOJ, EMA, FDA, MHRA, TGA, Biologics and biotechnology, Business Skills, Combination products, Crisis management, Distribution, Drugs, Ethics, Government affairs, Manufacturing, Medical Devices, Quality

Tags: Shkreli, generic drug pricing, Sarepta, biosimilars

FDA Warns Canadian API Manufacturer Following Adverse Event Reports By Zachary Brennan - Published 09 December 2015

After reports of serious adverse events surfaced for patients administered drug products compounded with an active pharmaceutical ingredient (API) from Quebec-based Medisca Pharmaceutique, the US Food and Drug Administration (FDA) inspected the company’s Pittsburgh-based site and found that the APIs were actually mislabeled and misbranded.

Categories: News, Canada, US, DOJ, FDA, Active pharmaceutical ingredients, Compliance, Crisis management, Distribution, Drugs, Government affairs, Postmarket surveillance, Quality

Tags: Medisca, somatropin, L-Citrulline, API manufacturing

US Government Agencies Crack Down on Dietary Supplement Manufacturers By Zachary Brennan - Published 17 November 2015

In partnership with the Department of Justice, Federal Trade Commission and other agencies, the US Food and Drug Administration (FDA), announced that after a yearlong sweep of dietary supplement makers, the agencies have filed civil injunctions and criminal actions against 117 manufacturers and/or distributors of dietary supplements and tainted products falsely marketed as dietary supplements.

Categories: News, China, US, DOJ, FDA, FTC, Compliance, Distribution, Manufacturing, Nutritional and dietary supplements

Tags: USPlabs, FDA, DOJ, FTC, dietary supplements, nutraceuticals, good manufacturing practices

Regulatory Recon: FDA Approves New Lung Cancer Drug, Companion Diagnostic (13 November 2015) By Zachary Brennan - Published 13 November 2015

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher , @Zachary Brennan and @RAPSorg on Twitter.

Categories: News, Asia, Europe, Latin America and Caribbean, Middle East, Oceania, US, CDSCO, CFDA, DOJ, EMA, FDA, Audit, Business Skills, Clinical, Compliance, Crisis management, Drugs, Due Diligence, Ethics, Government affairs, In vitro diagnostics, Manufacturing, Medical Devices, Orphan products, Postmarket surveillance, Preclinical, Quality, Regulatory intelligence, Regulatory strategy, Research and development

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Senators Investigate Rising Drug Prices as HHS Plans Action By Zachary Brennan - Published 04 November 2015

The fire stoked by rising drug prices is starting to spread through government, particularly as Sens. Susan Collins (R-ME) and Claire McCaskill (D-MO) on Wednesday announced a bipartisan Senate investigation into pharmaceutical price gouging with letters to four companies.

Categories: News, US, DOJ, FDA, FTC, Business Skills, Compliance, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: Elijah Cummings, Valeant Pharmaceuticals, drug prices, Senate investigation

Regulatory Recon: 21st Century Cures Struggles in the Senate (27 October 2015) By Zachary Brennan - Published 27 October 2015

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher , @Zachary Brennan and @RAPSorg on Twitter.

Categories: News, Africa, Asia, Europe, US, DOJ, EMA, FDA, FTC, MHRA, Biologics and biotechnology, Clinical, Drugs, Due Diligence, In vitro diagnostics, Medical Devices, Research and development

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

B-MS Pays $14M to Settle SEC Charges over Bribing Health Providers in China By Zachary Brennan - Published 05 October 2015

Bristol-Myers Squibb (B-MS) on Monday agreed to pay more than $14 million to the Securities and Exchange Commission (SEC) to settle charges that its joint venture in China made cash payments and provided other benefits to health care providers (HCPs) at state-owned and state-controlled hospitals in exchange for prescription sales.

Categories: News, China, US, DOJ, Audit, Biologics and biotechnology, Drugs, Due Diligence, Ethics, Government affairs, Regulatory intelligence

Tags: China, Bristol-Myers Squibb, SEC, FCPA, bribery

Senate Committee Advances Bill Redefining When a Drug is Officially Approved By Zachary Brennan - Published 01 October 2015

A bill that would effectively provide manufacturers with more certainty on the marketing exclusivity of approved drugs needing DEA clearance advanced unanimously through a Senate committee Wednesday.

Categories: News, US, DOJ, FDA, Drugs, Due Diligence, Government affairs, Postmarket surveillance, Regulatory intelligence, Regulatory strategy, Research and development, Submission and registration

Tags: Controlled Substances Act, DEA, FDA, drug approval, Improving Regulatory Transparency for New Medical Therapies Act

Regulatory Recon: EC, EU, WHO Now Sharing More Drug Data (23 September 2015) By Zachary Brennan - Published 23 September 2015

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher , @Zachary Brennan and @RAPSorg on Twitter.

Categories: News, Asia, Canada, Europe, US, DOJ, EC, EMA, FDA, WHO, Biologics and biotechnology, Drugs, Government affairs, Manufacturing, Medical Devices, Quality, Regulatory intelligence, Regulatory strategy

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Regulatory Recon: FDA Bans Imports from Another Indian Manufacturing Site (15 September 2015) By Zachary Brennan - Published 15 September 2015

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher , @Zachary Brennan and @RAPSorg on Twitter.

Categories: News, Asia, Europe, Middle East, US, DOJ, EMA, FDA, FTC, TGA, Clinical, Drugs, Government affairs, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

New Fundamentals of US Regulatory Affairs Book Now Available By Zachary Brousseau - Published 10 August 2015

The updated, ninth edition of Fundamentals of US Regulatory Affairs is now available. The book has been completely updated, and includes extensive, current regulatory information for pharmaceuticals, medical devices and biologics, and covers regulatory topics ranging from the history of food, drug and cosmetic laws to crisis management and FDA inspection and enforcement.

Categories: HTML, Articles, Under RAPS, US, DOJ, FDA, FTC

Tags: Fundamentals of US Regulatory Affairs, ninth editin, 9th edition, US Fundamentals, book, regulatory affairs reference

Keeping an Eye on Corporate Integrity Agreements By Sharon DeGrove Bishop, RAC - Published 23 June 2015

Even in the world of healthcare product regulation, the initials CIA still stand for surveillance and vigilance.

Categories: News, US, DOJ, FDA, Compliance, Ethics, Regulatory strategy

Tags: CIA, Corporate Integrity Agreement, RIQ, Graematter, Regulatory Intelligence Quotient