The FDA Law Blog

DECEMBER 8, 2022

Food and Drug Administration (FDA) issued two guidance documents, one draft and one final, on food allergen labeling requirements. 1, 2023; The applicability of food allergen labeling requirements to specific products (e.g., 1, 2023; The applicability of food allergen labeling requirements to specific products (e.g.,

Documentation 59

Documentation Labelling FDA Packaging 59

European Pharmaceutical Review

DECEMBER 20, 2023

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.

Labelling 84

Labelling Documentation 84

pharmaphorum

OCTOBER 30, 2022

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.

FDA 52

FDA Documentation Labelling Immunization 52

ISPE

MAY 11, 2023

Also, determining whether an intrusion occurred and documenting that intrusion adds to the challenges of performing aseptic technique properly (and perhaps adds to the subjectivity of the current control strategies). To establish that correlation, the ML algorithm was trained with labeled images, including borderline or edge cases.

Documentation 52

Documentation Labelling FDA 52

European Pharmaceutical Review

JULY 20, 2023

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].

Labelling 65

Labelling Documentation Hospitals 65

The Thyroid Pharmacist

JULY 14, 2023

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.

Dosage 97

Dosage FDA Immunization Documentation 97

ISPE

AUGUST 30, 2022

The Common Technical Document (CTD) for the Registration of Pharmaceuticals For Human Use: Quality—M4Q guidance covers the minimum requirements for submission of raw materials; however, certain regions have additional requirements. The absence of any of the listed documentation should be scientifically justified.

Documentation 52

Documentation FDA Packaging Communication 52