Legal/Regulatory

Lundbeck scores FDA approval, reorganizes

Lundbeck scores FDA approval, reorganizes

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The FDA approved the drug maker's depression drug Brintellix, one day after the Danish company announced a reorg that includes shifting 180 to 200 jobs.

Shutdown dims lights at FDA, NIH and CDC

Shutdown dims lights at FDA, NIH and CDC

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The midnight shutdown put 800,000 government employees on leave, including those at the FDA, NIH and CDC.

Industry ties may expand indications

A study of government drug review advisory panels suggests that those with members who have financial ties to the drug industry recommended expansion of labeled disease indications for the drugs examined

Stakeholders anxious over FDA data policy

Stakeholders anxious over FDA data policy

FDA stakeholders in industry and academia told the agency in August that they're concerned about its newest initiative to make clinical trial data more publicly available

Study links DTC ads, statin overuse

A study of prescription drug direct-to-consumer advertising suggests that it may promote over-diagnosis of high cholesterol and over-treatment for populations where risks of statin use may outweigh potential benefits.

FTC sees gain in high court pay-for-delay rule

FTC sees gain in high court pay-for-delay rule

The Federal Trade Commission (FTC) says that a June Supreme Court decision finding so-called pay-for-delay patent dispute settlements not inherently anticompetitive has put the agency in a stronger position to protect consumers from such settlements

Ruling shields scientific opinions

The Second Circuit Court of Appeals affirmed a New York federal court ruling that scientific opinions in a journal article could not give rise to claims of false advertising

FDA revising promotion guidances, says Abrams

FDA revising promotion guidances, says Abrams

The FDA is reviewing two drug-promotion guidances, according to CDER Office of Drug Promotion director Tom Abrams

FDA: Industry clamoring for breakthrough status

FDA: Industry clamoring for breakthrough status

FDA director of drug evaluation and research Janet Woodcock says she is amazed that FDA has had more than 30 requests for its new breakthrough therapy designations and it has granted 11 already.

New approval paths needed: report

Organization including the Pew Charitable Trusts are voicing basic suppor for FDA's efforts to develop an alternative approval pathway for certain drugs

FDA: Pradaxa fell prey to "stimulated reporting"

FDA: Pradaxa fell prey to "stimulated reporting"

FDA drug safety officials say that an influx of numerous bleeding reports associated with Boehringer Ingelheim's blood thinner Pradaxa (dabigatran) is a case of "stimulated reporting"

Drug quality is FDA's top 2013 priority: Hamburg

Drug quality is FDA's top 2013 priority: Hamburg

FDA commissioner Margaret Hamburg is urging the pharmaceutical industry to improve manufacturing quality

"Conditional approval" draws dissent

The idea of scaling back premarket clinical trials comes under fire

FDA mulls fast approval for unmet-needs drugs

FDA mulls fast approval for unmet-needs drugs

FDA is exploring an alternative drug-approval pathway for drugs intended to address unmet medical needs by "limited use" approvals.

FDA chief cites the need for more collaboration

FDA chief cites the need for more collaboration

FDA commissioner Margaret Hamburg says that if academia, industry, government scientists and regulators could come together more in pre-competitive collaboration it could get more done

Structure and staffing hold back FDA: study

Structure and staffing hold back FDA: study

A new report says that FDA still has significant workforce and management challenges in the scientific and medical arenas that need to be addressed

Lap-Band gets FDA Warning Letter

An FDA Warning Letter says that oBand Centers is making misleading claims in its promotional materials for the Lap-Band

FDA wants another look at data for failed drugs

FDA wants another look at data for failed drugs

FDA's drugs center wants to revisit a proposal once entertained by PhRMA to allow the agency access to all data from failed drug development programs to research whether different approaches could have saved the products.

FDA moves to streamline patient info

The FDA wants to replace Medication Guides, patient-package inserts, and other consumer medication information handed out at pharmacies with a proposed Patient Medication Information (PMIs) sheet

Panel: FDA needs more accelerated approvals

Panel: FDA needs more accelerated approvals

A White House scientific panel has recommended that FDA expand its accelerated approval program to a broader range of drugs.

PhRMA's principles for patient input

The Pharmaceutical Research and Manufacturers of America (PhRMA) has adopted "principles" to guide interactions between companies and patient organizations.

Feds add a new tool to fight fraud at drug firms

Feds add a new tool to fight fraud at drug firms

Used for the first time in the recent $3 billion healthcare fraud settlement with Glaxo­SmithKline (GSK), a new enforcement tool has joined the federal government's list of options to rein in improper medical product promotion.

FDA: Drugmakers share the blame for shortages

FDA: Drugmakers share the blame for shortages

FDA challenged a House report that said its regulations and enforcement actions contribute to drug shortages.

Court nixes payoffs to generic firms

An appeals court ruling says "any payment from a patent holder to a generic patent challenger who agrees to delay entry into the market" can be taken as "evidence of an unreasonable restraint of trade."

House panel blames FDA for drug shortages

House panel blames FDA for drug shortages

A new report from the House Committee on Oversight and Government Reform blames FDA for shortages of generic injectable medications.

FDA moves faster than EMA: study

A Yale assistant professor and a medical student have provided evidence that FDA's review process is faster than those in other countries.

Drug safety alerts almost double

An FDA report says the agency issued 68 drug safety alerts in 2011, an average of more than one each week and up 74% over the 39 alerts issued in 2010.

Ex-FDA Chief Calls for Fast 'Breakthrough' Path

Ex-FDA Chief Calls for Fast 'Breakthrough' Path

Legislation to speed FDA approval of breakthrough drugs is being supported by both former FDA commissioner Mark McClellan, now a Brookings Institution senior fellow, and Friends of Cancer Research chairperson Ellen Sigal.

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