Novartis hit with another 483 after FDA finds repeat failings
New Webinar With Highly Detailed FDA 483/WL Data! The FDA has hit Novartis with another 483 after finding seven repeat observations and a backlog of 1,360 overdue consumer complaints.
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FDA pushes worldwide, uniform device code
New Webinar With Highly Detailed FDA 483/WL Data! Millions of Americans are walking around with artificial joints, pacemakers, stents and other implants. But federal regulators know more about where a pallet of dog food went than a batch of hip replacements. Unlike prescription drugs or, for that matter, food at the grocery store, medical devices […]
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Pfizer, Ranbaxy Sued Over Alleged Anti-Competitive Scheme
New Webinar With Highly Detailed FDA 483/WL Data! Pfizer Inc. and Ranbaxy Laboratories Ltd. were sued in an antitrust case filed in federal court in New York alleging the drugmakers engaged in an anti-competitive scheme to delay a generic version of Lipitor into the market. The AFL-AGC Building Trades Welfare plan, a health and welfare […]
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Pharma Has Issues With Balancing Value Proposition
New Webinar With Highly Detailed FDA 483/WL Data! Source: Pharmalot There is a new survey finds that finds there are major differences of value when decision makers at big pharma, health insurers, regulators, government payers, generic makers and service providers were asked about the extent to which improved efficacy, patient outcomes, unmet medical needs, comparative […]
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Johnson & Johnson hit with FDA warning letter
More regulatory woes as Johnson & Johnson hit with a warning letter from the FDA regarding its insulin pumps. The FDA issued a warning letter to medical device giant Johnson & Johnson (NYSE:JNJ) saying that the company could face penalties including fines and injunction for failing to report incidents where its OneTouch Ping and 2020 […]
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Cardinal Health Inc. Pharmaceutical’s Work Suspended
The federal Drug Enforcement Administration on Friday suspended a Lakeland FL pharmaceutical facility’s Class 1 drug operation, placing a kink in the flow of medication to nearly 2,500 pharmacies across the Southeast, company officials said. In an emergency conference call with investors and the press Friday morning, Cardinal Health Inc.’s chairman and chief executive officer, […]
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Unions Vow To Fight AstraZeneca Job Cuts
In the wake of the massive job cuts proposed by AstraZeneca, a pair of unions in the UK that represent employees at two facilities are vowing to fight the layoffs. The drugmaker, you may recall, announced plans earlier this week to eliminate 7,300 jobs in from facilites in various locations and divisions, including 2,200 from […]
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Lilly Woes: Salary Freeze Hits Majority of Employees
Source: Pharmalot With many patent expirations on best sellers on the way, and struggling to rebuild its pipeline, Eli Lilly had decided that employees in most countries around the world, including its executive team, will not receive base pay increases this year, according to a filing made late last week with the US Securities and […]
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Insight: In PIP implant scandal, a ragged safety net exposed
In June 2000, when American medical regulators posted a warning letter on the Internet about problems at a breast-implant maker in southern France, French authorities didn’t pay much attention. A U.S. Food and Drug Administration (FDA) inspection had found some products manufactured by Poly Implant Prothese (PIP) were “adulterated,” the letter said. French regulators say […]
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Whistleblowers accuse FDA of spying, persecution
The US Food and Drug Administration (FDA) is being sued by its own scientists and doctors who allege they were spied on and persecuted by the agency for expressing safety concerns about the approval of medical devices. This legal action has prompted an investigation by a key lawmaker in the Senate. It’s claimed that the […]
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