Viewpoints

Will the next US President support the backbone of our industry?

Only the strong survive when it comes to pharmaceutical packaging and shipping.

Working together affords many unseen opportunities for pharmaceutical innovation.

Recent news stories have reported that FDA scientists have been suspected of leaking confidential, commercial, and trade secret information to the media.

PDA's strategic plan calls for maintaining valuable and effective relationships with global regulators.

Ties between the biotechnology industry and university research are crucial.

International trade can be great for business, but breaking border laws can put one in hot water.

Regulators in both the EU and the US have attempted to stimulate paediatric-drug development with incentives offering extended periods of patent protection, but are these actions having the desired effects?

Policymakers must balance fundamental issues involving access to medicines and pricing.

Manufacturers willing to report bad news about the supply can help reverse the shortage trend.

New law provides FDA with the resources it needs to safeguard drug supply chain.

Meticulous system configuration can prevent machines from taking over.

Germany has shifted from a market where the pharmaceutical industry could enjoy considerable pricing freedom to a sensitive market influenced by cost-containment policies.

The author discusses the regulatory requirements for electronic records contained in Title 21 CFR Part 211 and how they overlap with the requirements set forth in Title 21 CFR Part 11.

Careful attention to detail will help to prevent valuable assets from "melting" away.

Taking time to appreciate the industry's greatest achievements will inspire growth ahead.

Presidents of leading associations offer views on the industry's future.

Parallel trade has frustrated pharmaceutical manufacturers for years and now evidence has linked such trade to drug shortages in Europe. Parallel trade representatives have yet to respond, but will need to react quickly to salvage their reputation.

BIO is calling for a more patient-centric approach to user-fee reauthorization.

Does global development have to entail multiple comparability studies?

Even the slightest of errors in exponential calculations can cause the biggest of headaches.

The globalisation of clinical trials is putting pressure on the European Medicines Agency.

It's better to catch costly mistakes in the laboratory before they reach the accounting department.

Apple's experience with manufacturing facilities in China present opportunity for future best practice.

How niche strategies can offer mainstream potential for biopharmaceutical companies.

Collaboration can begin with a conversation.

Failure to disclose info may work sometimes, but eventually every question will be answered.

The importance of new drug trials to patients, the economy, and science.

In a world where product recalls can mean the end of a company, all batches must be perfect.

SOCMA's Bulk Pharmaceuticals Task Force outlines key goals and challenges for user-fee legislation.