The FDA Law Blog

JULY 10, 2023

After a firm submits a 510(k) to FDA, FDA will request still more information after a first-pass review. According to the 2 nd Quarter FY2023 MDUFA V Performance Report , FDA issued a request for additional information (AI request) on the first FDA review cycle for 63% to 68% of 510(k)s submitted in FY2018 to FY2022.

FDA 75

FDA Documentation Packaging Communication 75

pharmaphorum

NOVEMBER 20, 2020

The announcement is no surprise as earlier this week, Pfizer’s CEO Albert Bourla said the company was preparing to file phase 3 data from the vaccine known as BNT162b2 with the FDA after gathering the required amount of safety data. billion doses by the end of 2021. Feature image courtesy of NIAID/Rocky Mountain Laboratories.

Vaccines 96

Vaccines Documentation FDA 96

pharmaphorum

FEBRUARY 8, 2022

The FDA has dropped a bomb on Eli Lilly’s marketing application for cancer immunotherapy sintilimab ahead of an advisory committee meeting due to take place on Thursday. ” While ODAC could still decide to back the drug at the meeting, the FDA isn’t beholden to follow its experts’ advice. .”

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FDA Documentation Chemotherapy 52

Pharmaceutical Technology

APRIL 6, 2023

The US Food and Drug Administration (FDA) has accepted Accord BioPharma’s Biologics Licence Application (BLA) for HLX02 (a proposed trastuzumab biosimilar) to treat HER2 cancer types. Accord BioPharma is the US specialty division of Intas Pharmaceuticals. HLX02 is intended for adjuvant treatment of HER2-overexpressing breast cancer.

FDA 52

FDA Documentation 52

pharmaphorum

JANUARY 25, 2023

An FDA advisory committee has recommended approval of Cidara Therapeutics’ once-weekly antifungal therapy rezafungin, setting it up to become the first new option for severe infections caused by Candida species in a decade. Melinta is privately-owned, after emerging from bankruptcy protection in 2020.

FDA 52

FDA Documentation 52

pharmaphorum

OCTOBER 30, 2022

Shares in US biotech Y-mAbs Therapeutics have lost almost a third of their value after FDA advisors unanimously rejected its brain cancer therapy 131I-omburtamab in 16 to 0 vote. Changes in standard and supportive care over the time period could also have skewed the results, said the FDA reviewer.

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FDA Documentation Labelling Immunization 52

The FDA Law Blog

MAY 8, 2023

Javitt — FDA recently published a long-awaited draft guidance aimed at reducing the need for prior FDA authorization of modifications to artificial intelligence/machine learning (AI/ML)-enabled device software functions (ML-DSFs). a) , and related guidance documents (e.g., See 21 CFR 807.81(a)(3) a)(3) and 21 CFR 814.39(a)

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FDA Documentation Labelling 98

European Pharmaceutical Review

NOVEMBER 15, 2022

Validation projects have often been documentation-focused exercises, more befitting a grammar exercise than artifacts supportive of regulated activity. The GAMP 5 Second Edition guide emphasises that focus should be on value-adding activities rather than documentation for documentation’s sake.”

Documentation 98

Documentation FDA Pharmaceutical Companies Pharmaceutical Companies 98

European Pharmaceutical Review

SEPTEMBER 2, 2022

The sampling strategy must be supported by sound and properly cited sources whose conclusions must be presented as supportive elements in the study documents. The following four elements of sampling methodology were found to be under-documented in RMM effectiveness studies: Supporting documentation for country/region selection.

Adverse Reactions 96

Adverse Reactions Documentation Medical Schools Packaging 96

pharmaphorum

FEBRUARY 10, 2022

FDA advisors have voted against approval of Eli Lilly and Innovent Biologics’ cancer immunotherapy sintilimab, undermining hopes of a new, lower-priced option in the PD-1/PD-L1 inhibitor class. Lilly said that along with Innovent it would work with the FDA as it completes its review of the sintilimab application.

FDA 52

FDA Documentation 52

pharmaphorum

JULY 27, 2022

Of all products approved by the European Medicines Association (EMA) between 2017 and 2020, 68% are currently available in England, a figure that stands at 54% in Scotland. In addition, the median time between regulatory approval and the first patient receiving a first dose was 247 days in 2020 – an increase of 25 days since 2018.

Documentation 98

Documentation FDA 98

Pharmaceutical Technology

SEPTEMBER 15, 2022

The top 13 players reported more than 10% revenue growth, with BioNTech (3,834.4%), Moderna (2,199.1%), Pfizer (95.2%) and Regeneron Pharmaceuticals (89.1%) reporting a more than 80% year-on-year (YoY) revenue growth from 2020 to 2021, according to GlobalData’s Pharma Intelligence Centre Companies Database.

Vaccines 108

Vaccines Documentation Compounding FDA 108

European Pharmaceutical Review

JULY 4, 2024

In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. 3 Is two too few? 3 Is two too few?

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FDA Documentation Compounding Pharmaceutical Companies 103

The FDA Law Blog

OCTOBER 5, 2022

By Riëtte van Laack — On September 28, 2022, FDA announced the availability of the proposed rule for the implied nutrient content claim “healthy.” The term healthy, as an implied nutrient claim, was first defined by FDA in 1994. FDA also announced it would be re-evaluating the regulatory criteria for use of the “healthy” claim.

FDA 52

FDA Labelling Packaging Documentation 52

ISPE

SEPTEMBER 15, 2022

12 of February 2020 again received 2,000 comments from public consultation. The first draft for comments from industry stakeholders was published in 2017 and generated 6000 comments.

Documentation 97

Documentation FDA 97

The FDA Law Blog

FEBRUARY 29, 2024

156, as added by the 1984 Hatch-Waxman Amendments, for certain FDA-regulated products. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug.

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FDA Documentation 59

The FDA Law Blog

OCTOBER 3, 2022

HHS noticed an increasing trend of illegal kickbacks in connection with speaker programs and in November 2020, the Office of Inspector General issued a Special Fraud Alert on the topic. Today, these two documents are key in navigating speaker programs in the industry. See 42 U.S.C. 1320a-7b(b).

Documentation 105

Documentation 105

pharmaphorum

SEPTEMBER 28, 2022

“For example, in early 2020, we enrolled somewhere between 3,000 to 3,500 participants each week. In March 2020, when the pandemic hit, we had to pause in-person recruitment. Food and Drug Administration (FDA). But that also provided us with an unexpected finding.” About the author.

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FDA Documentation Dosage Pharmaceutical Companies 98

pharmaphorum

SEPTEMBER 21, 2020

Waylivra – its second drug – was rejected by the FDA in 2018 on concerns about its safety, including the risk of serious bleeding and low blood platelet count. Fantatic news for the FCS Community – NICE has issued a positive Final Evaluation Document (FED) for Volanesorsen. — Action FCS (@ActionFCS) September 18, 2020.

Documentation 80

Documentation FDA 80

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.

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FDA Labelling Documentation 52

Pharmaceutical Technology

JANUARY 6, 2023

In 2020, the Federal Trade Commission issued a report regarding settlements reached between brand and generic manufacturers in FY 2017 and noted that “for the first time since [FY] 2004, no settlement agreement in [FY] 2017 contains a no-[authorized generic] AG commitment.”. Gilenya is an oral medication for multiple sclerosis.

Documentation 97

Documentation FDA Hospitals Dosage 97

pharmaphorum

DECEMBER 29, 2022

The FDA granted full approval to Par’s generic on 28 March, 2013. According to court documents cited by Reuters, annual sales of Exforge in the US were over $400 million before generic versions reached the market. The post Novartis agrees $245m settlement over Exforge generics delay appeared first on.

Specialty Pharmacies 52

Specialty Pharmacies Documentation FDA 52

pharmaphorum

SEPTEMBER 29, 2022

In the United States, the Food and Drug Administrator (FDA) has so far published three draft guidance documents on patient-focused drug development, with a fourth expected in the coming months. EMA and FDA backing represents a huge step forward for patient centricity as a force for good in pharmaceutical development.

Documentation 98

Documentation FDA 98

European Pharmaceutical Review

JUNE 24, 2022

The US Food and Drug Administration (FDA) requires that manufacturers establish whether nitrosamines, including NDSRIs, could be present in active pharmaceutical ingredients (APIs) and drug products, using the “three-step mitigation strategy described in the agency’s guidance”. 2020, 24 (12), 2915–292. 2020; 24(9): 1558–1585.

FDA 52

FDA Documentation Compounding 52

The Checkup by Singlecare

DECEMBER 1, 2023

Food and Drug Administration (FDA) certifies the Red Dye 40 as safe for human consumption. Apart from Red Dye 40, there are eight other certified color additives approved for use in food by the FDA: Blue No. The FDA has denied any link between the two for years. The controversy surrounding Red Dye 40 The U.S. 1, Blue No.

Labelling 52

Labelling FDA Documentation 52

ISPE

MAY 9, 2023

Improvements have been observed by various regulatory agencies in Latin America for the acceptance and implementation of international standards—for instance, the ICH Common Technical Document (CTD) format. Additional required information beyond ICH guidelines, or non-value-added documents (e.g., 6, and 2.3.S.7 7 are required.

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Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52

The Checkup by Singlecare

DECEMBER 26, 2023

Yes, as of March 2020 , insulin is considered a biologic product by the FDA. It was first approved in June 2020. Regulatory bodies such as the FDA conduct thorough tests to confirm that they meet safety, purity, and potency standards. Is insulin a biologic medication? It was first approved in December 2021.

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FDA Communication Documentation 52

Hospital Pharmacy Europe

JUNE 8, 2023

A lack of transparency The importance of setting the primary outcome prior to commencing a study and not deviating from the original protocol, was first highlighted in 1990 by Jay Siegel , a physician and research scientist working for the FDA in the US.

Documentation 52

Documentation Communication Patient Care Hospitals 52

Pharmaceutical Technology

OCTOBER 5, 2022

These, along with other similar claims, meant Biogen owed potential damages of $1,036,900,151 to the US and the various States, as per court documents. Tecfidera was approved in 2013 to treat MS, and in August 2020, Mylan launched its first FDA-approved dimethyl fumarate generic to the market.

Documentation 59

Documentation Pharmaceutical Companies Pharmaceutical Companies FDA 59

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. The authors propose using Module 2.3

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. The authors propose using Module 2.3

Documentation 52

Documentation Dosage Packaging Communication 52

The Checkup by Singlecare

MAY 28, 2024

Because this product was approved fairly recently in 2020 , it will be quite some time before a generic version is available. The device is being prescribed as indicated by the Food and Drug Administration (FDA). You have a history of problematic hypoglycemia with documentation of specific hypoglycemic events.

Insurance 52

Insurance Documentation FDA 52

Pharmaceutical Technology

JUNE 30, 2022

More than 100 clinical trials were initiated in Georgia from 2020 to 2021, with the majority from international sponsors and a focus on managing Phase II-III multinational trials.

Documentation 52

Documentation FDA 52

Policy Prescription

APRIL 1, 2022

The alleged counterfeit drug sales were traced back to August of 2020 and continued well into 2021. To the extent that SafeChain sold any counterfeit medication, SafeChain was an unwitting participant and notified the FDA of customer complaints as required by law. Where’s the FDA? Time will tell. . Emphasis added). .

FDA 40

FDA Documentation 40

The Checkup by Singlecare

FEBRUARY 21, 2024

Food and Drug Administration (FDA) approves it for treating rheumatoid arthritis , systemic lupus erythematosus, and malaria. Hydroxychloroquine also received a surge in media presence as one of the many drugs used off-label in treating coronavirus after the pandemic that started in 2020.

Documentation 52

Documentation FDA Dosage Labelling 52

ISPE

JANUARY 9, 2023

It was time for ISPE to update this key guidance document to reflect technological progress. Concepts of computerized software assurance (CSA) as discussed in the US FDA Center for Devices and Radiological Health (CDRH) Case for Quality program 1 are also explored and applied. 15 September 2020. 1 June 2021.

Documentation 52

Documentation FDA Communication 52

ISPE

MAY 11, 2023

The FDA, PIC/S, and WHO have all emphasized the importance and benefits of data flows in their guidance on data integrity. 3 , 4 RAMI integrates all assets, including physical items, software, administrative shell, documents, and personnel. Many organizations already have documented process maps. Figure 3 shows all four steps.

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Packaging Documentation Communication Data Entry 52