FDA Law Blog: Biosimilars

APRIL 21, 2025

By John W.M. Claud & Michelle L. Butler Recent reductions in force (RIFs) and leadership changes at FDA are already affecting key agency functionsand as the administration plans a broader reorganization, the impact will likely grow. One area drawing increasing attention is how these changes will affect the drug development and review process.

Documentation

STAT

JANUARY 7, 2025

The brief, 20-page document, instead, focuses on AI models used to produce data that supports regulatory decision-making about the safety, effectiveness, or quality of drugs. The guidance does not, however, capture how AI is being used in drug discovery, the process of identifying and designing molecules, or in operational efficiency.

Compounding

STAT

JUNE 27, 2025

And so Hassan called on GSK to return the product to market and, meanwhile, asked for numerous documents concerning pricing, rebates and communications with regulators. This marks the second time in recent months that GSK has angered a lawmaker over the asthma inhaler switch.

Documentation

Drug Patent Watch

DECEMBER 10, 2024

Quality Documentation and Manufacturing Expertise CDMOs are experienced in generating high-quality documentation required for regulatory submissions and have extensive expertise in drug development and manufacturing.

Documentation

Express Pharma

JUNE 18, 2025

By offering comprehensive and audit-proof documentation, the platform aims to simplify regulatory approvals and reduce time-to-market for pharmaceutical companies. It contains revision dates, test results, certifications, and regulatory documentation. However, access to full documentation is restricted to existing customers.

Packaging

Express Pharma

JULY 21, 2025

He explained the difference between incidents and deviations, stating that deviations are departures from written procedures, while incidents are unplanned events, reinforcing the need for clear SOPs and proper documentation.

Pharmaceutical Manufacturing

Beckers Hospital Review

JULY 3, 2025

From detecting cancer and remote patient monitoring to streamlined documentation and automated prior authorizations, here are 15 proven clinical uses of AI — with results: Nearly 2,000 physicians and advanced practice providers at Altamonte Springs, Fla.-based based AdventHealth are using Nuance’s DAX Copilot ambient AI scribe.

Documentation

STAT

DECEMBER 30, 2024

The authors found references to skin tone, pigmentation, or race  in 4% of the documents submitted before the FDA made its suggestion to diversify skin tone testing in 2013.

Documentation

Express Pharma

MAY 29, 2025

Building internal safety protocols and maintaining comprehensive documentation are essential to meet these environmental and safety obligations. Regular audits, proper documentation, and legal vetting of contracts are necessary to avoid such issues. Falling short can mean serious consequences, including product recalls or export bans.

Documentation

European Pharmaceutical Review

DECEMBER 2, 2024

Considering its numerous benefits, such as the above, regulators therefore encourage drug manufacturers to use mass spectrometry together with ELISA analysis, or mass spectrometry analysis by itself, for control and documentation of product impurities, explained Alphalyse.

Documentation

STAT

MAY 27, 2025

We’ll be talking about all things Medicare Advantage. Details here on how to watch or attend!

Hospitals

Express Pharma

JUNE 20, 2025

Rising expectations for scientific rationale One consistent theme across FDA communications, including 483s, Warning Letters, and guidance documents is the demand for sound scientific justification behind design and operational decisions. Interventions were neither documented nor risk-assessed.

Documentation

Express Pharma

AUGUST 5, 2025

These included consistent implementation of current Good Manufacturing Practices (cGMP), effective document management and retrieval systems, and high standards of facility upkeep and hygiene. At the Chennai facility, the USFDA inspector highlighted several points of strength.

Documentation

Drug Patent Watch

JUNE 23, 2025

By systematically monitoring and analyzing these documents… Patent filings represent one of the most valuable yet underutilized sources of competitive intelligence in the pharmaceutical industry.

Documentation

Express Pharma

DECEMBER 23, 2024

He also stressed the importance of reviewing batch records and analytical records and the need for clear documentation practices. Dr Khurana stressed the importance of risk-based testing and the need for proper documentation. He mentioned the role of quality assurance in ensuring these practices are followed.

Documentation

Express Pharma

JULY 21, 2025

Emphasising a proactive rather than reactive approach, she urged organisations to mitigate risks through thorough root cause analysis (RCA) and systematic documentation. She highlighted the critical role of investigations and CAPA in ensuring compliance and preventing recurring quality issues.

Pharmaceutical Manufacturing

European Pharmaceutical Review

AUGUST 7, 2025

Successful collaboration therefore hinges on dynamic, well documented protocols for anonymisation, consent, role allocation, transparency and ongoing compliance, all balanced against the pace of AI driven innovation: Anonymisation versus technical utility: Only data that have been irreversibly anonymised fall outside GDPR scope.

Pharmaceutical Companies

Express Pharma

DECEMBER 30, 2024

He further highlighted the importance of thorough documentation, communication with regulators, and the need for a comprehensive understanding of the revised Schedule M guidelines.

Documentation

FDA Law Blog: Biosimilars

FEBRUARY 23, 2025

Manufacturers must evaluate device changes in the first instance to determine whether a new 510(k) is needed or, instead, whether documentation of the change and rationale for not seeking 510(k) clearance is sufficient. See 21 C.F.R. For example, in an October 13, 2023 WL to ReNovo, Inc.,

Documentation

Express Pharma

JULY 21, 2025

He noted frequent gaps in team understanding due to staff turnover and stressed the need for strong communication, confidentiality, and documentation practices. Emphasis was placed on treating contracts as living documents and aligning all operational actions with documented expectations.

Documentation

Express Pharma

AUGUST 11, 2025

Even when pharmaceuticals sit outside formal duty lines, tighter documentation, origin rulings and routing checks behave like a shadow tariff—raising landed costs and stretching timelines. Working-capital cycles lengthen as shipments face pre-clearance, documentation becomes more exacting and receivables reflect renegotiated terms.

Documentation

Drug Patent Watch

DECEMBER 11, 2024

Understanding FDA Product Specific Guidances Product Specific Guidances are documents issued by the U.S. Global Harmonization Efforts There are ongoing efforts to harmonize bioequivalence standards and PSG-like documents across regulatory agencies worldwide. This could further streamline the development process for certain products.

Drug Development

Pharma Manufacturing

JULY 14, 2025

Out of 202 Complete Response Letters issued between 2020 and 2024, 150 involved quality/manufacturing issues, according to the regulator’s newly released documents.

Documentation

Express Pharma

AUGUST 5, 2025

The certification followed an audit that examined the site’s documentation, processes, systems, and quality management standards. It has been fitted with systems and processes that meet EU standards for quality and regulatory compliance. The manufacturing unit covers 157,500 square feet, with dedicated areas spanning 53,000 square feet.

Dosage

Express Pharma

APRIL 9, 2025

Logistics4Pharma, a GDP-certified pharmaceutical logistics provider based in Frankfurt, has expanded its service offerings by integrating a comprehensive transit document service with customs-secured transportation into its existing portfolio. This addition builds on the companys existing temporary storage services under customs supervision.

Customer Service

NY Times

JULY 23, 2025

globally, would morph into an effort to detect disease outbreaks and sell American products, according to documents obtained by The Times. PEPFAR, the campaign to end H.I.V.

Documentation

Drug Patent Watch

DECEMBER 9, 2024

Ancient civilizations in China, Egypt, and India documented the use of herbs for healing. This patent was later revoked after the Indian government challenged it, citing ancient Ayurvedic texts that documented this use of turmeric. patent for the use of turmeric in wound healing.

Compounding

Express Pharma

JULY 21, 2025

Safety data in the studies were consistent with the well-documented safety profile of ILUMYA, which is approved for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. No new safety signals were identified in the INSPIRE-1 and INSPIRE-2 studies.

Documentation

Express Pharma

MARCH 19, 2025

hour workshop provided participants with direction, supplementary documentation, and hands-on learning, ensuring they were well-equipped to meet compliance requirements. He provided detailed responses on compliance challenges & documentation requirements. Close to 200 participants attended the online workshop.

Pharmaceutical Manufacturing

Express Pharma

JANUARY 10, 2025

.” She points out that, “Special attention is required when handling data related to children and minors, ensuring that verifiable consent is obtained from guardians and that consent management is robust and well-documented.

Documentation

European Pharmaceutical Review

JUNE 19, 2025

Document 9286/25. The European Medicines Agency (EMA) has published a draft reflection paper that signals a potential evolution in the regulatory landscape for biosimilar development within the EU. Brussels: Council of the European Union; 2 June 2025. Interinstitutional File: 2023/0131 (COD).

Biosimilars

ALiEM - Pharm Pearls

JANUARY 10, 2025

Other documented pharmacological causes of anisocoria include nebulized ipratropium bromide and scopolamine (14-19). EM Clinicians should consider exposure-related anisocoria in the differential diagnosis of infant patients with acutely asymmetric pupils.

Documentation

Beckers Hospital Review

JULY 24, 2025

Hospital for Special Surgery in New York City is deploying Abridge’s AI platform across its enterprise to streamline clinical documentation and improve care outcomes. Abridge’s ambient AI technology automatically detects the care setting, specialty and language of a clinician-patient interaction to generate real-time documentation.

Documentation

Express Pharma

JULY 23, 2025

Documentation – Ensure thorough, process-aligned SOPs and real-time CAPA management. The panel concluded that a phased, risk-based approach with clear documentation and management commitment is essential for successful compliance, particularly for MSMEs. Equipment – Prioritise automation and system upgrades for quality and efficiency.

Dosage

Express Pharma

JANUARY 10, 2025

For example, GPS-enabled systems can log client visits, verify completed appointments, and document time spent at each location. GPS tracking helps sales organisations achieve these goals by providing a clear record of when and where sales representatives have been.

Documentation

Beckers Hospital Review

JULY 2, 2025

According to court documents reviewed by Becker’s , Mr. Khan owned and operated labs in Texas as part of a conspiracy to submit false reimbursement claims for COVID-19 testing on samples that were never collected, mostly from uninsured patients.

Hospitals

STAT

MARCH 3, 2025

posted a document  proposing to strip public participation from much of the business his department conducts , STAT writes. We have changed our settings to accept postcards and telegrams, although Signal continues to work well, too. … U.S. Health and Human Services Secretary Robert F. Kennedy Jr.

Compounding