Regulatory Oversight

The US Food and Drug Administration issued a draft guidance for industry on the Submission of Summary Bioequivalence Data for Abbreviated New Drug Applications (ANDAs).

Although industry is tightening its belt, contract manufacturers across Europe are actually making out quite well by taking on additional projects and new roles.

GMP agents report on old products, aseptic violations, and unexpected emotions.

On March 3, the US Food and Drug Administration released a draft guidance for Industry entitled "Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products: Content and Format."

The source of a problem reveals itself after some investigation, or it may crash down on you.

The author tests the ruggedness of VRL viewing conditions and defines optimal viewing conditions.

With the economy down and multinational firms capitalizing on patents in developing countries, India's R&D sector still has a long way to grow.

The US Food and Drug Administration has released a draft guidance for industry entitled Influenza: Developing Drugs for Treatment and/or Prophylaxis.

GMP experts act fast to resolve some unusual and difficult problems.

Also, UCB will divest certain business in emerging markets to GSK; the KineMatik Group named Michael G. Jarjour president and CEO; more...

Last week, the US Food and Drug Administration issued a draft guidance for industry, Standards for Securing the Drug Supply Chain–Standardized Numerical Identification for Prescription Drug Packages, and launched a pilot program to help protect the pharmaceutical supply chain.

The US Food and Drug Administration issued its Draft Guidance for Industry on Submission of Laboratory Packages by Accredited Laboratories.

A draft guidance for industry titled "Good Importer Practices" has been released to provide importers guidance on the steps they can take to help ensure imported products comply with the relevant statues and regulations of the United States throughout a product's lifecycle.

Although its domestic market is on the rise, Pakistan's market conditions have not proved welcoming enough to keep foreign investors.

Readers give advice on their best approach to handling (batch) rejection

The US Food and Drug Administration issued a draft guidance, Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches.

A US Food and Drug Administration guidance issued Tuesday provides new recommendations to applicants who wish to designate proposed products as orally disintegrating tablets (ODTs).

The US Food and Drug Administration released a draft guidance document that contains questions and answers relating to new labeling requirements for over-the-counter drug (OTC) products that are marketed without an approved application under section 502(x) of the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006.

The US Food and Drug Administration has released Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics, which finalizes the draft from August 1999.

FDA's Final Rule titled "Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals" takes effect Monday, Dec. 8, 2008.

When accusations fly: 'Tis better to give than to receive.

While the world pulls itself out from one of the worst crises in decades, Indian pharmaceutical companies are trying to capitalize on falling company prices by increasing their takeovers.

The US Food and Drug Administration issued a draft guidance, Contents of a Complete Submission for the Evaluation of Proprietary Names, on Nov. 24, 2008.

The US Food and Drug issued a draft guidance on Tuesday, Nov. 18, titled Process Validation: General Principles and Practices for comment. The guidance is meant to serve as a revision to the 1987 Guideline on General Principles of Process Validation.

The Indian government may soon monopolize its pharmaceutical industry to cut costs and improve healthcare, but the move is sounding off alarm bells with the companies whose drug products are under review.

Production problems come in all shapes, sizes, and ... species.

The US Food and Drug Administration released a draft guidance that reviews the agency's plan to offer priority-review vouchers to companies developing new treatments for neglected tropical diseases.

To err may be human, but to really mess things up, you need management.

FDA has issued a Final Rule titled "Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals."

Differential pricing is making more than just an appearance in Asia's pharma market these days.