2014 Documentation Labelling 
FDA Law Blog: Biosimilars
APRIL 8, 2025
Indeed, since 2014, DPD facilitatedthe publication of 42 quarterly batches and dozens of stand-alone PSGs, plus three one-off batches of PSGs updated to align with recommendations in general guidance documents ( g. , Publishing virtually every GDUFA guidance and MAPP since 2014 to fulfill FDAs GDUFA commitments. 314.150(c).
Eye on FDA
AUGUST 2, 2022
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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Pharmaceutical Technology
JANUARY 6, 2023
The agreement outlined that Par would keep its generic equivalent off the market for as many as two years, delaying the generic launch till September 30, 2014. Novartis argued that the early release of Entresto generics could cause labelling inconsistencies. These actions allegedly led to the extension of Novartis’ patents.
Syner-G
AUGUST 9, 2022
Over the next year, IMPACT authored the following documents for the client: Pre-NDA meeting package. Working with the company’s electronic publishing vendor to ensure that fully-compiled, submission-ready documents were produced. 5 clinical study reports. and 2.7.4), and the Clinical Overview (Module 2.5).
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.
Eye on FDA
JULY 7, 2020
The drug in question is Schedule II drug and bears a Boxed Warning on its label, yet the link contained no risk information about the drug, despite the fact that there was present information about the benefits of the drug, according to OPDP’s letter. One of them was about the appropriate use of links.
European Pharmaceutical Review
JULY 4, 2024
However, as with drugs, dietary supplements require evidence that they are safe and that claims on product labels are truthful and not misleading. 1 For use as prescription drugs, a botanical product must be approved by the FDA: to date, only two have gained this approval. 2024 [cited 2024May]. Available from: [link] Barber S.
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