Search Results for Johnson

Showing 1 – 25  of 28

Sanofi and J&J Lead the Way With Clinical Trial Transparency, Study Finds By Zachary Brennan - Published 05 December 2017

Clinical trial transparency among large pharmaceutical companies is high, although opportunities for improvement remain, according to a study published Tuesday in the BMJ.

Categories: News, US, FDA, Clinical, Research and development

Tags: clinical trial transparency, Johnson & Johnson, Sanofi, Valeant, Allergan

Apple, Verily and J&J Among 9 Selected for FDA Digital Health Pilot By Zachary Brennan - Published 26 September 2017

US Food and Drug Administration Commissioner Scott Gottlieb took the stage Tuesday at AdvaMed’s MedTech conference in San Jose, California, unveiling the nine companies selected among 103 applicants to participate in the agency’s precertification pilot for digital health applications.

Categories: News, US, FDA, In vitro diagnostics, Medical Devices

Tags: Google, Verily, Johnson & Johnson, digital health, medical software

Senators to FDA: Where are the Alternatives to Mylan’s EpiPen? By Zachary Brennan - Published 25 August 2016

Five senators from both sides of the aisle sent a letter to US Food and Drug Administration (FDA) Commissioner Robert Califf on Wednesday seeking more information on what the agency is doing to help authorize the use of EpiPen competitors that could bring down the cost of the autoinjector.

Categories: News, US, FDA, Combination products, Government affairs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: EpiPen, Mylan, Robert Califf, Grassley, Klobuchar, Ron Johnson

EMA, MHRA, Janssen Warn of Increased Risk of Toe Amputation With Type 2 Diabetes Drug By Zachary Brennan - Published 11 May 2016

A two-fold higher incidence of lower limb amputation, primarily of the toe, has been seen in a clinical trial with canagliflozin, Janssen, the European Medicines Agency (EMA) and UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said in a letter to health professionals.

Categories: News, Europe, EMA, MHRA, Active pharmaceutical ingredients, Biologics and biotechnology, Crisis management, Drugs, Labeling, Postmarket surveillance

Tags: Janssen, Johnson & Johnson, Pfizer, GlaxoSmithKline, canagliflozin, Celgene, Novartis

WHO Pilot Project Speeds Approval of Janssen HIV Drug in 11 African Countries By Zachary Brennan - Published 19 February 2016

A World Health Organization (WHO) pilot project looking to bring already-approved drugs to Africa more quickly will continue into 2016 after four of 11 participating African national medicines regulatory authorities (NMRAs) approved Janssen’s pediatric HIV drug Intellence (etravirine).

Categories: News, Africa, WHO, Crisis management, Drugs, Government affairs, Regulatory strategy, Submission and registration

Tags: WHO, Johnson & Johnson, Africa drug approvals, African drug regulators

FDA Warns Cancer Center Over Unsanitary Conditions By Michael Mezher - Published 11 November 2015

The US Food and Drug Administration (FDA) has warned the Connecticut-based Johnson Memorial Cancer Center over unsanitary conditions in areas where the center prepares sterile drugs.

Categories: News, US, FDA, Compliance, Prescription drugs, Manufacturing

Tags: Form 483, Warning Letter, Johnson Memorial Cancer Center, ISO 7, ISO 5, HEPA Filters

New Calls for Supreme Court to Weigh in on Unilateral Drug Labeling, 'Product Hopping’ By Zachary Brennan - Published 10 November 2015

The US Supreme Court is considering two requests that could have an impact on US Food and Drug Administration (FDA) rules governing drug label changes, and whether brand name drug manufacturers have to take generic competition into account when pulling a product from the market.

Categories: News, US, FDA, FTC, Compliance, Drugs, Due Diligence, Labeling, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: Johnson & Johnson, Motrin, drug labels, FDA, product hopping, generic competition

Case Study: Regulatory Advertising and Promotion From a Fellow’s Perspective By John Riehl - Published 16 October 2015

This article discusses three components of Purdue University’s Regulatory Pharmaceutical Fellowship from a current fellow’s perspective followed by a candid interview.

Categories: Features, US, FDA, Advertising and Promotion, Business Skills, Drugs

Tags: drug advertising and promotion, FDA, Purdue University, Johnson & Johnson, Eli Lilly, regulatory pharmaceutical fellowship

J&J’s Regulatory Executives Groomed as Business Leaders By Zachary Brousseau - Published 09 December 2014

J&J’s innovative AcceleRAte program grooms regulatory professionals to be the company’s future business leaders.

Categories: Under RAPS, Career Development

Tags: Johnson & Johnson, J&J, business, leadership

J&J's Janssen Gets Second Untitled Letter in as Many Months as FDA Targets Xarelto Advertising Piece By Alexander Gaffney, RF News Editor - Published 19 June 2013

Categories: US, FDA

Tags: Untitled Letter, Janssen, J&J, Xarelto, Johnson & Johnson, Latest News, fair balance

Ben Venue, FDA Receive Approval for Consent Decree, Potentially Easing Drug Shortages By Alexander Gaffney, RF News Editor - Published 01 February 2013

Categories: FDA, Manufacturing, Quality

Tags: Ben Venue, J&J, Consent Decree, Shortages, Johnson & Johnson, Latest News, Drug Shortages, cGMP

Bloomberg: After Failing Testing, J&J Altered Approval Criteria for Now-Recalled Hip Implants Published 29 January 2013

Tags: J&J, metal-on-metal, Johnson & Johnson, DePuy

WSJ: Johnson & Johnson Looks to Ease Drug Shortages through Shared Manufacturing Plan By Alexander Gaffney - Published 09 October 2012

Tags: Ben Venue, J&J, Lipodox, Doxil, Shortages, Johnson & Johnson, Latest News, Drug Shortages, pharmaceutical

J&J Settles Court Cases In Advance of Testimony by Former FDA Commissioner By Alexander Gaffney - Published 05 October 2012

Tags: Shareholder, Risperdal, Janssen, J&J, Kessler, Settlement, Lawsuit, Johnson & Johnson, Latest News, regulatory

J&J to Pay Millions in Marketing Lawsuit Published 31 August 2012

Tags: Johnson, Risperdal, J&J, Settlement, Lawsuit, Latest News

Reports: J&J Reaches Agreement to Settle Lawsuit Over 'Tsunami of Regulatory' Problems By Alexander Gaffney - Published 13 July 2012

Tags: Shareholder, J&J, Settlement, Lawsuit, Johnson & Johnson, Latest News, regulatory

Reports: Johnson & Johnson to Pay $2.2 Billion to Settle Risperdal Marketing Probe By Alexander Gaffney - Published 11 June 2012

Categories: DOJ

Tags: $2.2 billion, Prosecutors, Risperdal, J&J, Antipsychotic, Settlement, Lawsuit, Fine, Johnson & Johnson, Latest News, regulatory

J&J Announces Planned Cessation of Vaginal Mesh Sales By Alexander Gaffney - Published 06 June 2012

Categories: FDA

Tags: Lawsuits, Regulatory Approval, Ethicon, Vaginal Mesh, J&J, Unapproved, Johnson & Johnson, Latest News, Sales

Senators Launch Investigation Into 'Dubious Marketing Practices' of Pain Pill Manufacturers By Alexander Gaffney - Published 10 May 2012

Tags: Baucus, American Pain Foundation, Collusion, Endo Pharmaceuticals, Purdue Pharma, J&J, Pain, Investigation, Letter, Johnson & Johnson, Latest News, Senate, Congress, Grassley, pharmaceutical, drug

J&J Antibiotic Approved Via 'Animal Rule' Pathway By Alexander Gaffney - Published 30 April 2012

Tags: Pneumonic, Plague, JNJ, Levaquin, Animal, J&J, Animal Rule, Johnson & Johnson, Latest News

AstraZeneca CEO Out as New J&J CEO Takes the Helm By Alexander Gaffney - Published 26 April 2012

Tags: CFO, AZ, Lowth, Brennan, Gorsky, Johnson, JNJ, CEO, Weldon, J&J, AstraZeneca, Latest News, head, leadership

J&J Earnings Drag as Regulatory Problems Accumulate By Alexander Gaffney - Published 18 April 2012

Categories: DOJ, EMA

Tags: Forecast, Gross, Problems, Prosecutors, Risperdal, J&J, Antipsychotic, Revenue, Lawsuit, Fine, Profit, Johnson & Johnson, Latest News, issues, regulatory

Arkansas Slams J&J With $1.2 Billion Fine for Risperdal Marketing Tactics By Alexander Gaffney - Published 12 April 2012

Tags: $JNJ, Arkansas, Risperdal, Janssen, Lawsuit, Fine, Johnson & Johnson, Latest News, pharmaceutical, marketing, drug

FDA Plans Meeting on Metal-on-Metal Hip Implants By Alexander Gaffney - Published 29 March 2012

Categories: FDA, CDRH, MHRA

Tags: AAOS, Johnson and Johnson, Metal on Metal, MoM, Hip Implants, Meeting, hip, metal-on-metal, DePuy, Latest News

NYTimes: J&J Privately Jettisoned Hip Implant Line After FDA Raised Questions By Alexander Gaffney - Published 23 March 2012

Categories: FDA

Tags: Sell, Inventory, nonapprovable, Implant, hip, Johnson & Johnson, Latest News, medical device