Angie Drakulich

The US Food and Drug Administration issued on June 25 a draft guidance for industry, "CMC Postapproval Manufacturing Changes Reportable in Annual Reports," to provide recommendations to drug applicants about the types of changes that may be included in annual reports.

The US Food and Drug Administration announced plans to revise CGMP regulations.

Last week, the steering committee and expert working groups of the International Conference on Harmonizaton met in Estonia to discuss progress on the ICH quality trio guidelines and other Step-4 documents.

Last week, USP and the Ukraine Scientific Pharmacopoeial Centre for the Quality of Medicines agreed to share standards for the quality, purity, strength, and identity of medicines.

About one month after the announcement of McNeil Consumer Healthcare's recall of children's liquid pain and allergy medications , the US Food and Drug Administration testified before the US House Committee on Oversight and Government Reform about the issue.

Industry and regulatory experts discuss excipient testing, regulatory expectations, supply-chain challenges, and pricing in this Speakers Roundtable. This article contains bonus online material and podcasts.

Late last week, the US food and Drug Administration's Transparency Task Force published a series of proposals on public disclosure policies.

The US Food and Drug Administration launched a program last week designed to "educate healthcare providers about their role in ensuring that prescription drug advertising and promotion is truthful."

Effective May 1, 2010, the US Pharmacopeia has revised its Pending Monographs Guideline to clarify that excipients are eligible for pending-monograph status and can ultimately be included in an official National Formulary (NF) monograph.

Agreement on standards for excipient qualification, development, and fair pricing is underway.

A Technical Forum featuring representatives from Dow Chemical, ISP, and DMV-Fonterra Excipients. This article is part of PharmTech's supplement "Solid Dosage and Excipients 2010."

A Q&A with the First Federation Chair, Patricia Rafidison.

New Draft Guidance for Solid Oral Dosage Forms Focuses on Physical Chemical Identifiers.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."

After several years of debate and review, the US Food and Drug Administration is calling for the removal of metered-dose inhalers.

The US Pharmacopeial Convention will hold its governance meeting next week in Washington, DC.

The European Medicines Agency's Management Board praised the European medicines regulatory network's handling of the 2009 H1N1 swine-flu pandemic.

Seventeen pharmaceutical markets are now ranked as "pharmerging," according to market-research firm IMS Health.

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

In the final phase of its transparency initiative, the US Food and Drug Administration seeks additional public comments about how it can increase its interactions with regulated industry.

The World Health Organization released new guidelines this week for the treatment of malaria and the first-ever guidelines on procuring safe and efficacious antimalarial drugs.

The US Food and Drug Administration and the European Medicines Agency are implementing a streamlined process to help regulators better identify and share information regarding orphan-drug and biologic products.

Less than a week after president Obama proposed a spending freeze on non-security related federal programs, the FDA released its fiscal year 2011 budget request, calling for a 23% increase.

Less than a week after president Obama proposed a spending freeze on nonsecurity-related federal programs, the US Food and Drug Administration released its fiscal year 2011 budget request, calling for a 23% increase.

The US Food and Drug Administration issued a draft guidance for industry, Assessment of Abuse Potential of Drugs, in late January.

FDA impersonators and counterfeit drugs threaten the public's trust in online pharmacies.

Leading experts share insight on the current and future direction of process analytical technology. This article contains bonus online material.

The US Pharmacopeial Convention (USP) is recalling USP 33?NF 28.

The United States Pharmacopeial Convention is recalling USP 33?NF 28.

The US Food and Drug Administration released a warning to the public on Dec. 29, 2009 about criminals posing as FDA special agents and other law enforcement personnel as part of an international extortion scam.

The European Medicines Agency recently released a reflection paper regarding the involvement of patients and consumers in the agency's activities.