Tech Talk

During the past two years, FDA has been looking more closely at enforcing Part 11 of the Title 21 Code of Federal Regulations regarding electronic records and signatures (see back story).

The potential of single-cell genomics took a step forward recently with the announcement by The Broad Institute and Fluidigm Corporation of a new research center focused on developing research methods and discoveries in mammalian single-cell genomics.

More than a year has passed since the FDA issued its guidance, “Process Validation: General Principles and Practices,”.

The world of drug development is littered with early-phase failures: drugs that were shown to be safe in Phase I trials, but which failed to show efficacy later on.

The pricetag of pharmaceuticals are coming under increasing scrutiny in today’s age of cost constraints.

FDA’s Lucinda Buhse has been spearheading the agency’s spectral library of excipients as a means to improving supply chain security of the pharma industry, particularly focused on raw materials entering US borders (there are 300 entry points in total).

Drug shortages, particularly those for sterile injectable drugs, took center stage last year. In response, industry and the federal government, including FDA,

Industry, the public sector, and individuals can play an important role in creating solutions.

In attending the exhibitions and conference sessions at Interphex 2012 this week in New York, we gain a pulse on the current and future state of pharmaceutical manufacturing.

Jim Miller of PharmSource gave a keynote talk this week at Interphex 2012 in New York City on the state of the industry’s outsourcing environment.

Abbott Laboratories submitted a Citizen’s Petition to FDA, requesting that the agency not consider any applications for biosimilar versions of its monoclonal antibody therapeutic.

In the last five years, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has seized counterfeit drugs worth more than £25 million ($41 million), but the war isn’t over yet.

The Obama Administration released last week the National Bioeconomy Blueprint. The report outlines steps that federal agencies will take to drive the bioeconomy.

PDA is hosting a few interesting workshops in the coming weeks on key topics facing the industry.

Here at ExcipientFest 2012, in connection with IPEC, rooms are full of attendees listening for ways to better follow GMPs, for best testing practices.

The past month has seen a lot of news about the pharmaceutical industry’s positive influence in developing countries.

Here at ExcipientFest 2012 in San Juan, excipient manufacturers and users are debating how to move foward surrounding the issue of atypical visible particles found in excipients.

Apr. 16, 2012 marked the closing date for submitting comments on FDA’s draft guidance documents clarifying the approval process for biosimilars.

Today in San Juan, at ExcipientFest 2012 in partnership with IPEC, Michael Beatrice of Abbott spoke about the seven deadly sins of quality management.

Last week Human Genome Sciences (HGS) rejected GlaxoSmithKline’s (GSK) unsolicited $2.59 billion bid for HGS or $13 per share.

For some time, the European Federation of Pharmaceutical Industries and Associations (EFPIA) has been working on developing a European verification system to help combat falsified medicines.

FDA’s Center for Drug Evaluation and Research (CDER) has been running an educational regulatory-based forum since 2005 to engage its international regulatory counterparts.

Here in sunny Arizona, PDA is holding its annual conference, a chance to present data and discuss all aspects of sterile manufacturing. The theme for the first day of sessions was personalized medicine.

Researchers at the Massachusetts Institute of Technology (MIT) recently developed nanoparticles that can be controllably triggered to synthesize proteins.

In February, I wrote that Roche could be in for a lengthy battle if it wants to acquire the gene-sequencing specialist Illumina.

The industry is increasingly adopting continuous processing models as it works to gain better process understanding and control, an approach that is being encouraged by regulators under the QbD paradigm.

In contentious three days of hearing on the Affordable Care Act, the Supreme Court now seems far more likely to overturn the landmark legislation.

Sterility assurance is a critical component in the planning and manufacturing of pharmaceutical products.

Provisions in the Affordable Care Act (ACA) drove out-of-pocket costs down, while increasing drug spending among 19 to 25-year-olds in 2011.