Tag Archives: period

  • New Data on the Inspection of Human Cell & Tissue Products by the FDA

    A recent report charting inspectional information by the FDA for human cell/tissue therapeutic products shows a marked increase in inspection activity. The period covered is 2003-2010 and reports an increase in the number of inspections by about 250%, with an average duration of each inspection of 40-45 hours. During that period, voluntary compliance actions taken by companies as a result of inspections has increased 255% and official action taken has increased 240%. This is against a background …

  • Microbiology: Transcending Waste With Lean Manufacturing

    … manufacturing along with its neglect of certain areas, especially quality assurance and microbial contamination testing, when implementing lean principles. Since most drug manufacturers use outdated and inefficient testing methods, this area is in critical need of waste and process-time reductions. Because standard testing methods require a minimum of three to seven days to yield results, during this period of product quarantine and testing resources are wasted instead of contributing to …

  • The Benefits of Using Pharmaceutical Consultants

    … 50 branded drugs increased by 7.82% in 2007 – almost double the annual US inflation rate. This increase follows on the heels of price increases of 6.73% in 2006 and 6.22% in 2005. Some drugs saw price increases in the double digits over a three year period. For example, from 2005 to 2007 Sanofi-Aventis raised the price of Ambien 70.1%, Glaxo increased the price of its Welbutrin antidepressant 44.5%, and the price of Shire’s Adderall XR was boosted by 33.5%. Pharmaceutical companies are …

  • Lean Manufacturing: What it means to the Pharmaceutical Industry

    Over the past decade or so, the pharmaceutical industry has sporadically attempted to embrace lean manufacturing. While a manufacturing philosophy that aims to reduce waste and boost productivity would certainly appear to be a good partner for this industry, so far the results have been less that optimum. This does not have to be the case, however.

  • How a Pharmaceutical Consultant Can Improve Business Health

    No doubt, things are tough—and getting tougher—for the pharmaceutical industry today, especially for the smaller companies. They now have to buckle down and find ways to operate far more efficiently than in easier times. Every drop of value has to be squeezed out of every dollar invested in R&D, production, distribution, marketing, and sales. And this is where pharmaceutical consultants can help.

  • FDA Inspection Wizard: What’s Scary Can Turn Out to Be a Piece of Cake

    … the subject had the medical condition under treatment and that excluded medications were not given to him or her during the study period. 3.After finishing the audit, the inspector will meet with the investigator to talk about the results.  Any inconsistencies will be registered on FDA Form 483, of which you will receive a copy. 4.The inspector will write an Establishment Inspection Report (EIR) that will be sent to the FDA for evaluation.  You will receive a letter after this evaluation is …

  • The Battle Brewing Over Vaccinations

    … When many of the parents refusing vaccinations were asked why they chose not to vaccinate their children they told officials that they were skeptical over the overall safety of vaccines, and skeptical about claims from the government.  When asked where they got this information, many were unsure, but many said they had heard varied concerns from other parents. The CDC feels that because diseases like the mumps, rubella, even polio, have been absent from our modern day society for a long period, …

  • How Will Obama Care Affect the Pharmaceutical Industry?

    … high, or more recently when the sector came under significant criticism for  huge profits during the period of economic corrections As pharmaceutical consulting firms point out, patents have expired, and generic availability has increased, meaning the industry has been forced to become more “lean and mean”. in its approach to generating revenues. This bill hits the industry with over $10B in increased taxes to pay for the expanded insurance coverage promised.  This is probably going to …

  • The Role of Interim Monitors in Divestitures

    … According to many expert pharmaceutical consultants and representatives, this frequent use of interim monitors in these up-front buyer situations, only illustrates the tremendous weight and influence the FTC puts on the protection of divested assets, even for a short period of time until the business is transferred to the buyer. While many companies may see interim monitors as yet another form of government intrusion in the pharmaceutical industry, many companies and the FTC do not.  They …

  • Failing an FDA Inspection

    … inspections, which won’t get any easier. One problem you might face in the wake of more and more failed inspections is the possibility of being disbarred.  This means that the FDA can debar you from having any activity in the company, or any company, with a pending or approved NDA or ANDA.  This could not only put your individual career on the shelf for quite a period of time, but can hurt your company in further tests down the line.  In fact, before any company with a submitted NDA or …

  • AAI, CONSUMER GROUPS ENCOURAGE CONGRESS TO BAN PATENT SETTLEMENTS AND RESTORE COMPETITION IN MARKET FOR GENERIC DRUGS

    … exclusion payments in pharmaceutical patent settlements should be banned. Today’s letter encourages Congress to go a step farther than simply banning the exclusion payments, calling on lawmakers to address the root cause of the problem:  the 180-day exclusivity period awarded to the first-to-file generic manufacturer.  This highly profitable period serves as the main incentive for a branded manufacturer to enter into an arrangement with the generic challenger.  By allowing other generic …

  • Important Information about Lab Ergonomics

    … when you need to stand for an extended period while pipetting. 2.    Computer workstation Some researchers spend long hours entering data with a keyboard and mouse over a very high bench, making the person elevate the arms excessively.  This is what you need to do: –    Install adjustable keyboard trays under the benches, and monitors at viewing distance between 18 and 30″ and with top of screen at eye level. –    Locate computers away from doors, entrances, and …