The FDA Law Blog

APRIL 8, 2025

OGDP is one of several offices in OGD, and it was composed of three divisions: the Division of Legal and Regulatory Support, the Division of Orange Book Publication and Regulatory Assessment, and the Division of Policy Development (DPD). Providing significant policy support to the annual update of the Orange Book Preface.

FDA 139

FDA Documentation Labelling 139

The FDA Law Blog

MAY 11, 2023

GSK skinny label case , the U.S. Specifically, the Government explained, “[t]he section viii pathway cannot function properly if FDA and generic manufacturers cannot rely on an NDA holder’s representations to the agency regarding which portions of the brand-name drug’s labeling teach patented methods of use.”

Labelling 72

Labelling FDA Documentation Communication 72

pharmaphorum

MAY 25, 2022

Since COVID-19 reared its head more than two years ago, the traditional hustle and bustle of in-person annual congresses have largely been consigned to the history books. Here, we take a look at the top five takeaways from the document: 1. Identifying the appropriate code and label. The codes still apply.

Documentation 105

Documentation Communication Labelling 105

The FDA Law Blog

AUGUST 10, 2022

Koblitz — For years , FDA has been wrestling with questions about what patents should be listed in the Orange Book, but, as we have reported, FDA has made little to no progress on addressing those questions. One of those pressing questions that remains unanswered involves the listing of REMS patents in the Orange Book.

FDA 52

FDA Labelling Documentation 52

Pharmaceutical Technology

JANUARY 6, 2023

According to the legal documents , the plaintiffs accused the companies of “violating federal antitrust laws, alleging “per se” and “rule of reason” violations”. Novartis argued that the early release of Entresto generics could cause labelling inconsistencies.

Documentation 97

Documentation FDA Hospitals Dosage 97

The Thyroid Pharmacist

DECEMBER 7, 2022

Several years ago, after reading research about all of the toxins commonly used in flame retardants (and learning about all of the many products in my home that contain these chemicals… somewhat of a shocking list), I looked at my mattress label, only to learn it contained one of the chief offenders. Labels (Furniture, Fabrics, and Carpet).

Health and Personal Care Stores 80

Health and Personal Care Stores Labelling Immunization Compounding 80

DiversifyRx

MAY 26, 2023

Ensure you have all cleaning products and items for decluttering, like storage bins, binders, or labels. Here are some of my favorite books to help with this: Eat The Frog, The One Thing, and 7 Habits of Highly Effective People. Hire extra babysitters, meal plan, and stock favorite employee drinks.

Independent Pharmacies 40

Independent Pharmacies Documentation Labelling Vaccines 40