Some Lessons Learned from 2011 Warning Letters
Earlier this week, we examined the Warning letters that came from FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC). Today we’re going to look at a few of the communications lessons learned from same – and reminding us that when in doubt, consult legal and regulatory resources. New Webinar Oct. 12 – Avoid FDA […]
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FDA issues draft guidance on trials for high-risk devices
The US Food and Drug Administration (FDA) has issued draft guidance on the design of pivotal clinical studies to support pre-market approval (PMA) applications for Class III medical devices. New Webinar Oct. 12 – Avoid FDA Recall Nightmares – Update from FDA Branch Chief for CDRH Recalls Class III products are the highest-risk category of […]
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FDA, industry reach generic drug fee agreement
U.S. regulators and generic drugmakers have reached a compromise agreement for a user-fee program that would require the companies to pay some $299 million in the first year to accelerate drug approvals. New Webinar Oct. 12 – Avoid FDA Recall Nightmares – Update from FDA Branch Chief for CDRH Recalls The Food and Drug Administration […]
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Generics Deal Sounds Alarm for Foreign API Makers
Foreign API makers unaccustomed to hosting FDA visitors may soon have to get their houses in order. A deal through which generics makers would pay $299 million in annual user fees to the FDA could fund the T&E to deliver U.S. regulatory inspectors to plants in India, China and elsewhere that now provide 80% of […]
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Changes Are Afoot in U.S. Medical Device Regulations
For the past couple years, the Food and Drug Administration has been reviewing the regulatory process that most medical devices use to reach the U.S. marketplace, the 510(k) pathway. After delaying decisions last year on its own hot-button recommendations until the Institute of Medicine released its (very controversial) report this summer, the FDA recently made […]
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AstraZeneca Pays $2.5M To Settle AWP Lawsuit
Once again, a big drugmaker has made a payment to a state in order to settle charges of inflating the average wholesale prices of its medicine. This time, AstraZeneca agreed to pay $2.5 million to Idaho, which argued its citizens were harmed because the state Medicaid program unnecessarily paid too much for various drugs. New […]
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Pfizer Cuts Reps Before Lipitor Patent Expires
This should not come as a surprise. The big drugmaker just two months ago disclosed plans to cut another $1 billion or so in expenses, with a first phase that will amount to $500 million in cutbacks taking place this year. The move, of course, comes in response to the loss of patent protection for […]
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Governments Want Price Cuts & Pharma Squawks
As Washington looks to shrink overwhelming deficits, the pharmaceutical industry is gearing up to fight any plan to seek more discounts and rebates for Medicare. Having contributed $112 billion to health care reform last year, drugmakers are bolstering their lobbying efforts and are warning that any move to extract more money will cost them a […]
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Pfizer Confesses About ‘Potential’ Overseas Bribes
In another instance in which a drugmaker appears to have bribed overseas officials, Pfizer has “voluntarily†provided the US Department of Justice and the US Securities and Exchange Commission with information concerning “potentially improper payments made by Pfizer and Wyeth personnel in connection with certain unspecified sales activities outside the US. The move comes amid […]
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Adventrx Shares Nosedive on FDA Rejection, Accusations of Bungled Study
The FDA has rejected Adventrx’s Pharmaceuticals’ ($ANX) application for a reformulated chemotherapy after regulators accused researchers of bungling a bioequivalence study. While the developer quickly mounted a defense of its study, investors clawed out a big chunk of the San Diego-based company’s value in after-market trading. Its shares were down about 60 percent this morning. […]
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