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The FDA’s hold on approving Croatian drugmaker Pliva’s drug applications imposed after the agency cited it for current good manufacturing practice (cGMP) violations has been lifted, the company said.
Recent guidance issued by Health Canada spells out requirements for sponsors, qualified investigators, and ethical review boards regarding the preparation, maintenance and availability of clinical trial records.
Under new regulations passed by the European Parliament, drug companies that research the safety and efficacy of their products in children will get a six-month patent extension.
The Australia Therapeutic Goods Administration TGA) and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) have unveiled a draft rule on the proposed regulatory scheme for medicines under the planned merger of the two agencies.
A panel of the Eighth U.S. Circuit Court of Appeals June 22 overturned a ruling in a case where a Missouri policy denied Medicaid device coverage to most of the state’s adult program recipients.
Vintage Pharmaceuticals, a generic drug manufacturer, has pleaded guilty to felony charges of distributing adulterated drugs through interstate commerce.
In the wake of recent scandals over data falsification, the FDA announced its ongoing commitment to protecting human clinical research subjects at a June 21 press conference at the Drug Information Association’s annual conference in Philadelphia.
Radio-frequency identification (RFID) is increasingly seen as the technology of choice for the pharmaceutical industry to use in combating theft and counterfeiting of prescription drugs and, due to federal action, will soon become a de facto industry standard. The FDA has urged the pharmaceutical industry for years to implement RFID to comply with its impending requirement for electronic tracking of drug shipments. But the industry has been slow to act, mulling over the effectiveness of the technology, the costs of implementation and privacy concerns. That will soon change, as the FDA now has a firm deadline for compliance with electronic tracking, making what was once a novelty an everyday part of the manufacturing and shipping process. This delay has allowed the technology to evolve to become more efficient. Miniature tags can now be attached to individual pill bottles, instead of merely cases and pallets. These can be read, quickly, with scanners from a convenient distance. In some newer models, the tags can be partially or completely erased once they are no longer needed, easing privacy concerns. Even without federal action, pharma companies have seen pressure from the marketplace and their competitors. Wal-Mart now requires all its suppliers, not just drugmakers, to use the technology, and major pharma companies like Purdue are putting it on some of their most popular and most widely abused drugs. FDL explores the challenges industry faces implementing RFID and examines how several of the major players are doing it.
The FDA has requested more safety information before it will allow Pozen and GlaxoSmithKline to market their migraine drug Trexima, the companies said.