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.

Sundlof Resigns as FDA's Head of Food Safety; and More

In an effort to standardize quality agreements for active pharmaceutical ingredients in the drug industry, the Bulk Pharmaceuticals Task Force, an affiliate of the Society of Chemical Manufacturers and Affiliates, has developed a template to help manufacturers and customers comply with US regulatory requirements in a simplified manner.

The European Ombudsman has recommended that the European Medicines Agency review its refusal to grant public access to reports on adverse drug reactions.

Week Of May 10, 2010: Company And People Notes: Ariad and Merck Restructure Collaboration; Genzyme Changes Leadership; and More

In response to stringent price cuts introduced in Spain, the European Generics Association (EGA) is urging the Spanish government to adopt mechanisms that will help increase the dispensing of generic medicines.

2016 will see Pfizer continue to cling to first place in the top ten pharma list, but Merck & Co. and Novartis will not be far behind.

The biotechnology markets in the United States, Europe, and Canada, and Australia reached aggregate profitability in 2009, according to Ernst & Young.

The US Food and Drug Administration sent a letter to trade associations of manufacturers, wholesalers, and pharmacies to recommend procedures for preventing and responding to the theft of regulated products.

McNeil Consumer Healthcare is voluntarily recalling all lots that have not yet expired of certain over-the-counter children's and infants' liquid products.

European Parliament Approves Proposals On Falsified Medicines and Pharmacovigilance; And More.

FDA Approves AstraZeneca's and Pozen's Vimovo; Merck Announces Management Changes; And More.

Vetter has signed a preferred partnership with Sentry BioPharma Services whereby Vetter will fill early-stage, high-value biopharmaceuticals at its Chicago facility and Sentry will label, package and ship the clinical supplies from its site in Indianapolis.

Defining the Next Five Years.

FDA wants industry to talk to them about the science underlying process innovations-really.

The growth of Brazil's generic-drug market is on a fast track, but what are the projections for the sector's future?

A book helps statistics novices prepare to comply with the US Food and Drug Administration's draft guidance on process validation.

A Pharma Business Imperative.

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

When vessels, seals, and cooling units go haywire, operators must get in the mix.

The author proposes techniques, based on Six Sigma methods, for monitoring such processes to discover their airflow patterns and reduce opportunities for spillage.This article is part of PharmTech's supplement "Solid Dosage and Excipients 2010."

Over the last few months, we have been publishing a series of special features, which have sought to provide you with an overall view of current challenges, innovations and trends in niche pockets of the pharmaceutical industry.

A new automated factory in Boston (MA, USA) has been developed that uses non-genetically modified green plants to quickly produce large quantities of vaccines and therapeutics.

The European Medicines Agency published a summary report that includes suggestions for improving the current processes for evaluating benefit-risk.

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

Charles River Acquires WuXi AppTec; Amgen Appoints President and COO; and More.

Genzyme provided an update on its manufacturing operations following the issuance of a draft consent decree by FDA regarding the company's Allston Landing, Massachusetts, manufacturing plant.

FDA Issues Warning Letter To Pfizer; And More.