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Speaking of Medicine – Mid-Year OPDP Enforcement Review

Eye on FDA

There are two means of gaining insight into the agency’s thinking about regulatory issues related to promotional communications by pharmaceutical companies; one is through the issuance of guidance documents, the other is through enforcement. But when it comes to enforcement things have changed greatly over the years.

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Trial bias concern scuppers Y-mAbs brain cancer drug in FDA vote

pharmaphorum

The two groups were also separated by a sizeable time difference, with data from the control group ranging between 1990 and 2015, while Study 03-133 started enrolling patients in 2004. Changes in standard and supportive care over the time period could also have skewed the results, said the FDA reviewer.

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EU pharmaceutical legislation revisions: what are the implications for biopharma?

European Pharmaceutical Review

In October 2023, the European Parliament (EP) proposed revisions to the European Commission proposals with diverging views on various topics set out through two documents. In October 2023, the European Parliament (EP) proposed revisions to the European Commission proposals with diverging views on various topics set out through two documents.

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Lasers for Thyroid Tissue Regeneration

The Thyroid Pharmacist

Fortunately, my colleague Dr. Kirk Gair from West Covina, CA, who is also a Hashimoto’s patient, has used cold lasers in his clinic since 2004 and has developed protocols that combine LLLT with chiropractic modalities. Individual doctors may still be able to utilize this therapy with their patients as an “off-label” use. Ross, DS.

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Botanical drugs – what is the best way forward for regulatory and market approval?

European Pharmaceutical Review

However, as with drugs, dietary supplements require evidence that they are safe and that claims on product labels are truthful and not misleading. 10 Directive 2004/24/EC introduced a registration scheme for traditional herbal medicines and requires herbal remedies sold over the counter in the UK to be registered. 2012/1916).

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Preparing for stricter standards on substances of human origin

European Pharmaceutical Review

SoHO entities must implement a traceability system to unmistakably link each SoHO donor to their SoHO donation and to all documents, samples, SoHO preparations and SoHO entities that are associated with that SoHO from the point of collection to human application and outcome monitoring. Cited 2023Mar].

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To Be or Coco-Not To Be: That’s One Question Answered in FDA’s Final Guidance Documents on Food Allergens

FDA Law Blog: Biosimilars

Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act This final guidance replaces previous draft and final guidance documents on food allergen labeling that FDA issued in November 2022, which we discussed in a previous post. By Sophia R.