FDA Law Blog: Biosimilars

JUNE 11, 2023

However, over time, data on pediatric labeling changes pursuant to BPCA and/or PREA have been collected. Between 2002 and 2019, there were 768 products with pediatric labeling changes under BPCA and/or PREA. Still, however, it appears FDA has had enough of these 16%.

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Labelling Drug Development 40

FDA Law Blog: Biosimilars

OCTOBER 2, 2023

However, the two previous FDA guidance documents, released in May 1998 ( Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products , available here ) and December 2019 ( Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products , available here ), differ from the new guidance.

Drug Development 64

Drug Development Documentation Labelling Medical Records 64

FDA Law Blog: Biosimilars

MAY 8, 2023

FDA recommends manufacturers submit each modification, associated labeling changes and specific performance evaluation in the Modification Protocol (MP). Update procedures : The MP should describe how the manufacturer will update the software and any associated labeling that will be required for the modifications.

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Documentation Labelling 98

FDA Law Blog: Biosimilars

JULY 10, 2023

Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 For labeling documents and the 510(k) summary, FDA often requests both clean and redlined versions. Average Number of Industry Days to MDUFA IV Decision 54.69 Average Number of Total Days to MDUFA IV Decision 127.31

Documentation 75

Documentation Packaging Communication Labelling 75

pharmaphorum

JANUARY 14, 2021

The promotional environments of major pharmaceutical markets were already divergent in 2019 – some, like Italy and Spain were very high on traditional face to face interactions, others, like the UK, were the complete opposite, and still others, like Japan and the US, had high volumes of both digital and face to face contacts.

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Biosimilars Pharmaceutical Companies Pharmaceutical Companies Labelling 71

pharmaphorum

NOVEMBER 3, 2021

Around one in five gastric cancers are HER2-positive, opening up a new market for AZ and Daiichi Sankyo, which have been collaborating on Enhertu since signing a multi-billion partnership for the drug in 2019. The post EMA starts review of Enhertu for HER2+ gastric cancer appeared first on.

Chemotherapy 98

Chemotherapy Biosimilars Labelling 98

FDA Law Blog: Biosimilars

AUGUST 21, 2023

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. A recent state law failure-to-warn case in the SDNY makes that very point.

Labelling 40

Labelling Vaccines Communication 40

Pharma in Brief

JANUARY 25, 2023

Changes to how the PMPRB reviews prices In 2019, the federal government introduced amendments to the Patented Medicines Regulations (the Amendments ). Such cases typically concern “skinny labels” in which the generic seeks to avoid reference to indications related to the patented use.

Biosimilars 52

Biosimilars Dosage Labelling Compounding 52

PharmaShots

APRIL 13, 2023

Novartis intended to separate its eye care division, Alcon, into an independent company which is expected to be completed in 2019. summing the revenue to $29.63B In the year 2019, Roche held the second position among the top 20 biopharma companies with the sales of $63.5B stake in GSK Consumer Healthcare to GSK.

Biosimilars 40

Biosimilars Vaccines Pharmaceutical Companies Pharmaceutical Companies 40

FDA Law Blog: Biosimilars

JUNE 2, 2023

“All In” Manufacturer Definition CMS believes that the National Rebate Agreement (NRA) requires a “manufacturer” to report to Medicaid all of its covered outpatient drugs, under all of its labeler codes. This includes newly acquired labeler codes and newly formed subsidiaries. See 42 U.S.C. 1396r-8(b)(3)(C)(iii).

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Labelling Vaccines Drug Pricing Immunity 59

pharmaphorum

FEBRUARY 26, 2021

Robert Wood’s granddaughter, Mary Lea, was the first baby to be used on the baby powder label. billion) hit the company in 2019. But like many of its big pharma peers, it faces increased pressure on some of its biggest brands, as expiring patents pave the way for generic competition while biosimilars undercut sales of biologics.

Vaccines 126

Vaccines Biosimilars Labelling Communication 126

PharmaShots

APRIL 3, 2023

The system offers alternative options for those patients receiving other medications The system was originally approved in 2019 for treating chronic pain. The authorization incl. multiple indications such as RA & Crohn's disease Hyrimoz was originally approved by the EC in 2018 with a concentration of 50mg/mL.

Biosimilars 40

Biosimilars Diabetes Compounding Hospitals 40

FDA Law Blog: Biosimilars

DECEMBER 18, 2023

The letters come on the heels of FDA finalizing its Guidance on Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements. Both letters addressed quantitative efficacy presentations—attacking the numbers as well as the underlying methodology for obtaining those numbers.

Labelling 59

Labelling Pharmaceutical Companies Pharmaceutical Companies 59

RX Note

FEBRUARY 23, 2023

Terazosin - Off-label use in ureteral stone(s) expulsion Topical Corticosteroids - Apply thinly on the skin using fingertip unit. Statins - Not all statins need to be taken at night.

HIV Treatment and Prevention Agents 58

HIV Treatment and Prevention Agents Community Pharmacies Labelling Chemotherapy 58

FDA Law Blog: Biosimilars

NOVEMBER 7, 2024

Provided that a brief device description, clear intended use, and list or picture of all labeling claims are made, FDA aims to review the information and provide a response generally within 7 days. According to the latest MDUFA performance report , only 25% of 513(g)s in fiscal year 2023 met the 60-day statutory time frame.

Documentation 69

Documentation Labelling 69

pharmaphorum

FEBRUARY 5, 2021

The FDA did go on to add warning labels in the following years and eventually decided to require a class-wide monitoring programme, with training for doctors. Abernethy only joined the agency in 2019 and although she clearly has some fresh ideas about how the FDA could be run, she lacks Woodcock’s experience in the organisation”.

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Vaccines Biosimilars Labelling 119