Regulatory Oversight and Compliance

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

FDA is poised to gain authority and resources to ensure the quality of food and drugs.

On March 3, the US Food and Drug Administration released a draft guidance for Industry entitled "Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products: Content and Format."

In a press release dated Feb. 25, 2009, the US Food and Drug Administration charged that Ranbaxy Laboratories's (Gurgaon, Haryana, India) Paonta Sahib facility falsified data and test results in approved and pending drug applications.

Broader disclosure of drug prices and conflicts of interest are central healthcare reform issues.

The US Food and Drug Administration has released a draft guidance for industry entitled Influenza: Developing Drugs for Treatment and/or Prophylaxis.

The stimulus bill expands the healthcare safety net while boosting investment in health IT and comparative research.

Efforts to cut healthcare outlays will focus on drug costs, despite a drop in prescription sales.

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Last week, the US Food and Drug Administration issued a draft guidance for industry, Standards for Securing the Drug Supply Chain–Standardized Numerical Identification for Prescription Drug Packages, and launched a pilot program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The US Food and Drug Administration issued its Draft Guidance for Industry on Submission of Laboratory Packages by Accredited Laboratories.

A draft guidance for industry titled "Good Importer Practices" has been released to provide importers guidance on the steps they can take to help ensure imported products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.

The US Food and Drug Administration announced that it had filed a Consent Decree on Dec. 23, 2008 and was awaiting the court?s entry of a permanent injunction that bars Actavis (Hafnarfjordur, Iceland), its officers Sigurdur Oli Olafsson and Douglas Boothe, and its subsidiary Actavis Totowa (Totowa, NJ) from manufacturing and distributing drugs at the Actavis Totowa facilities.

The generic-drug manufacturer Actavis reached an agreement on a consent decree of permanent injunction with the US Food and Drug Administration regarding the company?s US subsidiary Actavis Totowa LLC.

Will more resources and new leadership fix FDA, or is a major overhaul in order?

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.

To expand coverage amidst the economic crisis, Obama will look for ways to cut healthcare costs.

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.

Although the number of annual new-drug approvals in the United States has steadily declined during the past ten years, pharmaceutical companies still prefer to introduce new products in the US first, according to a report published by the Tufts Center for the Study of Drug Development.

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.

Policymakers weigh new rules to ensure the safety and quality of drugs made with tiny particles.

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.

Manufacturers seek real-world benefits from investment in QbD and risk-management strategies. This article contains bonus online-exclusive material.

Although the European Union's approval rates of biosimilars for market is increasing slower than expected, its approach may provide an example for other foreign markets.

FDA is taking several measures to ensure that imported drugs meet manufacturing standards.

FDA has finalized a regulation regarding changes to an approved new drug application (NDA), biologics license application (BLA), or medical device premarket approval applicatin (PMA).

The US Food and Drug Administration issued a new draft guidance for public comment on sterile manufacturing.