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Drug Safety

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Latest From Drug Safety

Gottlieb Talks Activist Role For FDA In Curbing REMS Abuse

US FDA commissioner says he would be happy to work with Congress on a legislative solution on the issue, but emphasized his priority is for the agency to develop a system itself to discourage REMS abuse.

Drug Safety FDA

Liability Win For Industry As US Supreme Court Curtails Forum-Shopping

State courts cannot exercise specific jurisdiction over personal injury claims brought by out-of-state residents, high court says in favorable decision for Plavix marketer Bristol-Myers Squibb. Ruling likely to result in smaller mass tort lawsuits, but more of them across the country.

Legal Issues Distribution

REMS Class-Action Lawsuit Against Celgene Is First By Patients

Patients For Affordable Drugs Founder David Mitchell alleges Celgene's unlawful delay tactics like REMS obstruction kept generic versions of Thalomid and Revlimid off the market, forcing plaintiffs to pay higher costs.

Drug Safety Generic Drugs

Rx 'Reformulation' In Herbal Sleep Aid Gives FDA A Nightmare

FDA inspects Belmora's website and product labeling in March and issues a warning letter that firm’s Elavil OTC Sleep Aid is an unapproved new drug with inadequate directions for its intended use.

Consumer Drug Safety

Postmarketing Studies On Abuse-Deterrent Opioids Could Get New Look

Data sources and methodologies to evaluate real-world effects of abuse-deterrent formulations will be focus of US FDA public meeting in July; value and feasibility of assessing the public health effects of such products more broadly is up for discussion.

Post-Marketing Studies Drug Safety

Generic Savings: REMS Obstruction, Not ANDA Backlog, Is Main Hindrance, AAM Says

Association for Accessible Medicines report highlights continuing upward trend of cost savings from generic drugs; trade group argues legislative proposals addressing restricted distribution misuse are key to accelerating savings.

Pricing Debate Generic Drugs

Opana Withdrawal Request Builds On US FDA Actions On Palladone, OxyContin

Earlier withdrawals of Purdue’s Palladone and original OxyContin create precedent for request that Endo’s Opana ER come off market due to risk of abuse; former chief counsel sees agency's move as ‘tip of the iceberg’ on opioid safety actions.

Drug Safety Post Market Regulation & Studies

Opana ER Should Come Off The US Market, FDA Tells Endo

Agency seeks long-acting opioid’s withdrawal due to evidence the reformulated version increased intravenous abuse; FDA’s action, which Endo is weighing, portends a hard-line stance when it comes to opioid risks under new Commissioner Scott Gottlieb.

Drug Safety Post Market Regulation & Studies

Perrigo’s Latest Woe: Empty Emergency Contraceptive Packages Recalled

Perrigo is recalling is Option 2 (levonorgestrel 1.5 mg) emergency contraceptive in US and Canada because the tablet is missing from some of 181,776 one-count packages.

Consumer Recalls
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