The Pharma Data

MAY 4, 2021

The US Food and Drug Administration (FDA) and pharmaceutical industry groups met twice in April to discuss the reauthorization of the Biosimilar User Fee Act (BsUFA) after kicking off negotiations in March. . Posted 04 May 2021 | By Michael Mezher .

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Science Biosimilars FDA Production 52

Drug Channels

OCTOBER 5, 2021

Click here to download a free report overview (including a summary of industry trends, the Table of Contents, and a List of Exhibits) New Drug Channels Institute Study: Biosimilars Are Delivering Higher Profits for Drug Distributors (press release) We’re offering special discounted pricing if you order before October 15, 2021! Section 4.4.

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Pharmaceuticals Biosimilars Licensing Licensing 75

Agency IQ

AUGUST 2, 2024

An earlier iteration of that report detailed how the agency wanted to change some of its practices surrounding the publication of guidance documents. However, the draft document was somewhat FDA-focused, and industry asked the agency to incorporate other ideas into the final version. This is what OIRA is currently reviewing.

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FDA Science Regulations Biosimilars 40

Drug Channels

OCTOBER 10, 2023

Drug Distribution Industry Gaining from Anti-Obesity Drugs and Provider-Administered Biosimilars (press release) We’re offering special discounted pricing if you order before October 20, 2023! There are loads of internal hyperlinks to help you navigate the document and customize it to your specific interests and priorities.

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Pharmaceuticals Specialty Pharmacies Pharmacy Biosimilars 40

Agency IQ

JULY 8, 2024

In early June, we’re expecting to see what the FDA will allow life sciences companies to do in this fight as it releases a new draft guidance document. In early June, we’re expecting to see what the FDA will allow life sciences companies to do in this fight as it releases a new draft guidance document.

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FDA Science Regulations Production 40

Agency IQ

APRIL 26, 2024

Updated guidance on promotional labeling for biosimilars and interchangeables emphasizes a similar approach Today, the FDA issued a revised draft guidance on the development of promotional labeling for biosimilars, reference products, and—newly—interchangeable products. regarding its administration, preparation, storage, or safety).

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Biosimilars Science FDA Licensing 40

Agency IQ

MARCH 1, 2024

There are also some product-specific bioequivalence guidelines open for comment, along with concept papers proposing the development of materials on the topics of biosimilar development and non-inferiority comparisons in clinical trials.

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Regulations Biosimilars Clinical Trials Production 40

FDA Law Blog: Biosimilars

NOVEMBER 6, 2023

Compared with the COVID-centered version of the document released in April 2021, there is very little that is new or different. RIEs will require the facility to accommodate the “use of teleconference, livestream video, and screen sharing of data and documents.” We should explain what RIEs are.

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FDA Compliance Clinical Trials Drugs 105

Agency IQ

DECEMBER 1, 2023

Positive *Biosimilar **Generic Notable comment periods closing in December Below are various deadlines regarding E.U. policy, such as public registers, drafts, reflection papers, concept papers and guidance documents expected to close in December.

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Regulations Clinical Trials Production Biosimilars 40

FDA Law Blog: Biosimilars

AUGUST 16, 2023

Document dumps,” he said, are not helpful without the assistance of a narrative placing the documents in context.

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Compliance FDA Drugs Pharmaceuticals 97

Drug Discovery World

JULY 25, 2023

It has been a very busy period recently for paediatric drug development with the release of many guidance documents from two notable regulatory agencies. They are required for orphan drugs but not for biosimilars. PIPs are mandatory for applicants seeking marketing authorisation for new medicines in the EU.

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Drug Development Clinical Pharmacology Pharmacokinetics Drugs 130

FDA Law Blog: Biosimilars

JUNE 8, 2023

It is also crucial to maintain a respectful and cooperative demeanor, document the meeting discussion and action items, and promptly address follow-up actions. FDA notes that all in-person FTF formal meetings at CDER and CBER will have a hybrid component (virtual attendees in addition to in-person attendees).

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FDA Biosimilars Production Government 53

FDA Law Blog: Biosimilars

JUNE 10, 2024

Submit documentation as evidence of addressing the observations (e.g., Document all corrective actions and follow-up to ensure sustained compliance. Provide a method of verifying or monitoring the effectiveness of the actions. training, standard operating procedure (SOPs), corrective action plans, records, etc.).

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FDA Law Blog: Biosimilars

JUNE 27, 2023

FDA also requests a “detailed description of the allegation with any available supporting documentation.” In our experience, the more detailed the documentation that accompanies the submission, the more likely FDA will follow-up on the submission.

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FDA International Regulations Production 59

FDA Law Blog: Biosimilars

FEBRUARY 9, 2024

Baumhardt, Senior Medical Device Regulation Expert — As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations , in late December. By Adrienne R. Lenz, Principal Medical Device Regulation Expert & Lisa M.

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FDA Compliance Regulations Engineering 105

Agency IQ

JANUARY 19, 2024

Seventeen products were orphan drugs, fourteen were generics and eight were biosimilars. Reviews of orphan medicines and biosimilars have remained stable over the past three years. There were eight biosimilars reviewed in 2023, which is comparable to 2021 (seven) and 2022 (eight), but lower than 2020, which saw 12 biosimilars reviewed.

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Biosimilars FDA Production Treatment 40

FDA Law Blog: Biosimilars

MAY 6, 2024

The guidance does not define “on a reasonably justified regular cycle” or “as soon as possible” but instead recommends manufacturers should “update appropriate cybersecurity documentation (e.g., Appendix 4) for the documentation requirements to “demonstrate reasonable assurance that the device and related systems are cybersecure”.

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FDA Regulations Marketing Drugs 105

FDA Law Blog: Biosimilars

SEPTEMBER 11, 2023

Lenz, Principal Medical Device Regulation Expert — On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents.

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Regulations FDA Marketing Science 64

FDA Law Blog: Biosimilars

APRIL 25, 2023

The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. Through a recent (and very short) Guidance document, FDA indicated that, starting on October 1, 2023, FDA may base “refuse to accept” (RTA) decisions on the information required by section 524B.

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FDA Regulations Production Drugs 105

FDA Law Blog: Biosimilars

JUNE 27, 2024

DEA recently revoked the registration of Coconut Grove Pharmacy (“Coconut Grove”), like Gulf Med Pharmacy also in Florida, for its failure to resolve prescribing red flags and document such resolution. Coconut Grove Pharmacy; Decision and Order, 89 Fed. 50,372 , 50,377 (June 13, 2024). 50,372 at 50,372-73.

Pharmacy 52

Pharmacy Drugs Regulations Compliance 52

FDA Law Blog: Biosimilars

FEBRUARY 5, 2024

Her expertise includes preparation and maintenance of licensing documentation, communications with state boards and government agencies, conducting research, and the preparation of associated licensing documentation and applications.

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Licensing Licensing Pharmacy Regulations 45

The Pharma Data

APRIL 6, 2021

No PRIIPs key information document has been prepared as not available to retail in the EEA. No UK PRIIPs key information document has been prepared as not available to retail in the UK. It will have a portfolio of more than 60 trusted medicines that address an entire spectrum of conditions women face.

Regulations 52

Regulations Biosimilars Government Production 52

Agency IQ

JUNE 29, 2023

The notice specifically made mention of a 2018 draft guidance document, Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements, and noted that “it is not fully understood how consumers will interpret specific quantitative claims.” print, electronic, audiovisual, broadcast).”

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FDA Drugs Regulations Biosimilars 40

FDA Law Blog: Biosimilars

JUNE 28, 2023

As part of that effort, Accreditation Scheme for Conformity Assessment (ASCA) is designed to reduce FDA review time, reduce and/or remove Sponsor guesswork on documentation to provide in a premarket submission, and improve the quality of testing conducted.

FDA 52

FDA Laboratories International Regulations 52

FDA Law Blog: Biosimilars

APRIL 19, 2023

The new draft guidance continues to borrow heavily from the NDA process and FDA notes that it used the same source material on which other drug application recommendations are based including the Common Technical Document (CTD). x 11-inch paper, and with hyperlinks to references and numbered pages.

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FDA International Drugs Marketing 59

FDA Law Blog: Biosimilars

OCTOBER 16, 2023

Just a day earlier, FDA’s Center for Devices and Radiological Health (CDRH) released a list of the guidance documents the Center intends to publish in the upcoming 2024 fiscal year.

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Regulations FDA Production Disease 119

Agency IQ

MARCH 29, 2024

Comment periods for EMA documents (such as concept, reflection, and guidance papers) generally stay open for at least six months, though these timelines can vary drastically. regulatory framework Webinar/ Seminar ( OPEN ) EMA 4/17/2024 4/17/2024 CEP 2.0: regulatory framework Webinar/ Seminar ( OPEN ) EMA 4/17/2024 4/17/2024 CEP 2.0:

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Regulations Production Biosimilars Clinical Trials 40

FDA Law Blog: Biosimilars

AUGUST 9, 2023

As with other required controlled substance records, electronic records documenting EPCS transfers must be maintained for two years from the transfer date by both the transferring and receiving pharmacies. to be codified at 21 C.F.R. to be codified at 21 C.F.R.

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Pharmacy Regulations Licensing Licensing 52

FDA Law Blog: Biosimilars

JULY 7, 2024

Section IV, Additional Resources, provides links to previously-issued guidance documents and other educational materials geared to traditional device manufacturers, with no additional commentary on how to apply these requirements to the very different clinical laboratory environment.

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Compliance Laboratories FDA Regulations 64

The Pharma Data

APRIL 8, 2021

No PRIIPs key information document has been prepared as not available to retail in the EEA. No UK PRIIPs key information document has been prepared as not available to retail in the UK. It will have a portfolio of more than 60 trusted medicines that address an entire spectrum of conditions women face.

Regulations 52

Regulations Biosimilars Government Production 52

FDA Law Blog: Biosimilars

JUNE 16, 2023

After a manufacturer submits (or fails to submit) the required drug cost statement, the AG may petition a court to issue an order to, inter alia : compel the manufacturer to provide the required drug cost statement or additional information, including by answering interrogatories, producing documents, or being examined under oath; restrain or enjoin (..)

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Drugs Biosimilars Production Treatment 45

FDA Law Blog: Biosimilars

JUNE 20, 2023

The document provides minor updates on procedures, incorporating recent developments and experiences in how FDA interacts with industry. Like other guidance documents that preceded it, the draft guidance will be open to the public for comment. Once final, the guidance will be implemented and review staff will be trained.

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FDA Regulations Marketing 45

FDA Law Blog: Biosimilars

AUGUST 18, 2024

In effect, these documents serve as road signs helping to direct new market entrants. The agency has done far better in posting 510(k) summaries, which are similar types of documents. FDA has said that these summaries need to go through multiple levels of review, but that cannot excuse delays of 500 days or more.

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FDA Hospitals Production Regulations 69

FDA Law Blog: Biosimilars

FEBRUARY 7, 2024

In brief, in regard to proof of identity, the seller must obtain sufficient information to identify and document the identity of the purchaser. Thus, such persons are subject to identification, recordkeeping, and reporting requirements. 1310.06.

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Regulations Compliance Government Production 116

Agency IQ

MARCH 1, 2024

For that reason, even if document rooms are open during the lapse period, those rooms will not be considered to have received physical submissions of such new applications during that period. What are the impacts for regulated industry? There’s quite a bit that we know from recent shutdowns – and some things we don’t.

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Government FDA Biosimilars Regulations 40

Agency IQ

JULY 8, 2024

Negative *Biosimilar **Generic Notable public consultation periods and calls for evidence Below are various deadlines regarding European policy, such as public registers, drafts, reflection papers, concept papers, and guidance documents expected to close into Q3 2024.

Regulations 40

Regulations Pharmaceuticals Production Compliance 40

Agency IQ

MAY 3, 2024

FDA’s Diversity Action Plan guidance: The FDA’s hotly-anticipated revised draft guidance document is currently under review at the White House’s Office of Information and Regulatory Affairs (OIRA), and we anticipate that it will be published over the next two months. Read the full list of documents on FDA’s Unified Agenda here.]

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