FDA reform bill regarding inspection & recalls.
Posted on November 16th, 2009
Recently there has been a reform bill that sees the FDA with more power over inspection, enforcement and recalls when it comes to food safety. What this means is:
- More frequent inspection of food plants (a change from every 5 years to possibly every six months)
- Companies will need to provide electronic records to FDA more frequently
- The FDA will require safety plans for all food facilities
- And the most important for most people; it would give the FDA the right to mandate certain recalls and hand out stiffer penalties when needed.
To read more about all the specifics of the bill, visit the Food Freedom blog.
Posted in FDA, regulations | No Comments »
Packaging, Labels & Regulations
Posted on November 2nd, 2009
As of 2006 the FDA made certain requirements for drug product labeling which meant an increase in the size of package inserts. They added the need for certain content to be present on the label and made adjustments to the font sizes and design requirements.
Now add European packaging, labeling and inserts to the mix. Not only are there strict requirements overseas in terms of labeling, but they also have numerous languages to account for. They are now considering the use of expanded content labels instead of having to have various SKUs for different languages. Phew…that’s already a lot to think of…
Just to extend it a little further now…in Europe there is an October 2010 deadline that specifies that some information be printed in Braille on cartons. This deadline will likely be extended even further seeing as there is still much work to be done to establish the proper guidelines as far dot height and measuring dot quality.
This brings up an interesting topic; with all these modifications to the package insert, how will they keep it accurate? What sorts of quality control or label inspection solutions do they have in place? And to even further that, will these changes ever stop long enough for a proper process to be put in place?
Tags: packaging, pharmaceutical labeling, regulations
Posted in Braille, FDA, Packaging inspection | No Comments »
Pharmaceutical labels: is the FDA telling the whole truth?
Posted on October 27th, 2009
Would you believe it if we told you that many key drug facts are left off pharmaceutical labels? Some of these facts could be life threatening, as is the case of a specific osteoporosis drug. If the dosage of this drug is increased slightly it could result in death. This critical information was not included on the label. Instead it was hidden in the FDA’s reviews, which are usually hundreds of pages long and filled with medical terms – making it impossible for a patient to find.
The FDA is required to approve the drug if the drug’s ability to prevent or cure a disease outweighs its side effects. It then becomes the responsibility of the pharmaceutical manufacturer to write the label and decide what information should be included. These labels have been known to play up the benefits and leave out harmful side effects. As the FDA is still responsible for approving the final label, drug experts are asking them to make this type of critical information more accessible to the public and to doctors alike. Fact boxes is what some experts are recommending. Dr. Lisa Schwartz and Dr. Steven Woloshin say that this will help patients to make more informed decisions, after all it is their health and they have a right to know!
See what else they are saying in Therapeutics Daily.
Tags: FDA, pharmaceutical, pharmaceutical labeling
Posted in FDA, Label inspection, packaging articles | No Comments »
