Regulatory Oversight and Compliance

In any industry, inspections can be a pain, and pharma is no exception.

FDA issued a draft guidance for industry on Mar. 11, 2011, titled User Fee Waivers, Reductions, and Refunds for Drug and Biological Products, that offers recommendations to applicants seeking such actions under the Federal Food, Drug, & Cosmetic Act (FD&C Act). A similar draft guidance was issued in July 1993. The new document clarifies the types of waivers, refunds, and reductions available under the user-fee provisions of the FD&C Act as well as the procedures for handling these requests, including how to appeal an FDA decision.

Last Thursday, FDA filed a consent decree of permanent injunction against McNeil, a subsidiary of Johnson & Johnson, for failing to comply with current good manufacturing practice requirements. The action prevents McNeil from manufacturing and distributing drugs from its Fort Washington, Pennsylvania, facility until FDA determines that its operations comply with the law.

FDA announced on Mar. 2, 2011, that it is taking action against companies that manufacture, distribute, or market certain unapproved prescription oral cough, cold, and allergy products, according to an agency release.

Ongoing Free Trade Agreement (FTA) negotiations between the EU and India have hit a hurdle as some stakeholders urge the Indian government to fight against certain provisions in the FTA amid fears that access to generic drugs may be affected.

Indian manufacturers are not a near-term threat to Western CMOs, but may be long term.

Brazil develops its first national plasma fractionation plant.

Just when things seem to be looking up, the unexpected problem occurs.

As drug shortages make headlines, FDA tests the Sentinel safety system and its efect on healthcare.

The recent India–EU summit was expected to bring news about the upcoming Free Trade Agreement between the EU and India; however, a dispute regarding the supply of generic drugs from India to developing countries has taken centre stage.

India is set to become a "biosimilar powerhouse", with manufacturers in this country well placed to capitalize on the growing biosimilars market, according to market analysts at Datamonitor.

On Feb. 4, 2011, the European Medicines Agency released new document on drug products that are manufactured using stem cells.

The European Medicines Agency has released a new Annex 11-Computerized Systems to its GMP Guide Chapter 4 on Documentation to account for the increased use of and complexity of computerized systems in the drug-manufacturing community.

As biologic-drug patents move toward expiration in the US, Indian firms with experience in the follow-on biologics arena are eager to partner with global manufacturers and secure their place in the growing biosimilars market.

Food-safety, transparency, and counterfeit-drug growth will tax agency resources.

Taking care to note, file and re-check information can save one from future mishaps.

The author describes why statistical significance would impose an unreasonable burden on manufacturers.

FDA published its long-awaited guidance titled Process Validation: General Principles and Practices this week.

Johnson & Johnson's run of quality issues, recalls and other bad news continues with yet another product recall.

FDA issued a draft guidance for industry on Jan. 18, 2011, about the size of beads within drug products labeled for sprinkle.

The European Commission and Medicines Agency seem to be moving in advance of their ICH partners to update standards.

Top priorities for manufacturers include user fees, new health initiatives, and regulatory compliance.

Sometimes doing what you think is right ends up being completely and utterly wrong.

The author explains the idea of equivalence and describes how it can facilitate equipment validation.

With the increasing need for businesses to reduce costs and demonstrate value, there is a requirement to look at all aspects of bio/pharma drug development and manufacturing to achieve efficiency improvements.