Regulatory Oversight

The author describes the new IPEA excipient good-manufacturing-practice certification program that is now ANSI accredited. This article is part of a special issue on excipients and solid dosage.

New Draft Guidance for Solid Oral Dosage Forms Focuses on Physical Chemical Identifiers. This article is part of PharmTech's supplement "Solid Dosage and Excipients 2010."

FDA made available a draft guidance that would expand the information disclosed about conflict-of-interest waivers.

An evaluation conducted by Ernst & Young assessing the effectiveness and efficiency of the European Medicines Agency has largely praised the agency; however, a number of strategic and operational recommendations for further improvements have also been made.

Laboratory personnel share interesting tales as well as stories of unexpected tails.

As demand for global vaccine development and production grows, all eyes are turning to Asia.

In an attempt to strengthen safeguards against counterfeit, diverted, subpotent, misbranded, adulterated, or expired drugs, FDA issued a new final guidance for industry.

FDA issued a new guidance for industry to help new drug applicants write the dosage and administration section of their products' labels.

The US Food and Drug Administration recently published guidance for the characterization and qualification of cell substrates, viral seeds, and other biological materials used to manufacture viral vaccines for human use.

Could President Obama's tax reform, which is targeted at reducing outsourcing, endanger India's contract-services industry?

From last-minute product inserts to putting out fires, close calls are a common occurrence.

FDA Releases Annual Guidance Agenda; OMB Urges Obama to Issue Revised Executive Order.

Sharing too much-or too little-information can have disastrous onsequences.

Regulators and industry move to require inspections of API manufacturing facilities.

New York Governor Wants Stricter Limits On Pharmaceutical Marketing; And More.

Directors and staff miss the mark when it comes to following procedures.

Blame it on cafeteria gossip, outdated procedures, and major miscommunication.

Also, FDA and WebMD increase collaboration and PPD is awarded contract to evaluate the agency's postmarket spontaneous-adverse-event surveillance system.

New tests solve one issue, but cheaper plastic and new stoppers cause problems.

New pricing controls and healthcare reforms may be pushing the pharmaceutical market out of this southeast Asian country. This article contains bonus online-exclusive material.

The US Food and Drug Administration issued a guidance for industry and review staff titled, Labeling for Human Prescription Drug and Biological Products-Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information.

The US Food and Drug Administration published its first draft guidance for industry about Risk Evaluation and Mitigation Strategies (REMS) on Sept. 30, 2009.

Pharmaceutical companies in India have had a hold on the biotechnology sector for many years, and they're not about to let the follow-on biologics market pass them by.

Like life, the workplace also can have many surprises.

The FDA issued a proposed rule to clarify the cGMP requirements applicable to combination products in the Federal Register.

The US Food and Drug Administration last week issued the final draft of its guidance for industry titled Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Questions and Answers.

Also, FDA issues several recent enforcement letters to Cambrex, Johnson & Johnson, and Pedinol.

Thanks to their keen observations, these auditors reveal the true culprits of deviations.

Designated as a "pharmerging market," Brazil is revamping its pricing models.

The author describes the approach taken to develop a facility dedicated to handling potent and cytotoxic drug substances.