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Brenda Sandburg

New York, NY
Brenda Sandburg is a senior writer who covers legal issues and FDA regulatory policy, with a particular focus on patents, biosimilars, and government investigations. She spent 10 years writing for legal publications between stints at The Pink Sheet and blends these experiences to provide in-depth analysis of events. An aspiring photographer, she enjoys taking photos to accompany news stories.
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Latest From Brenda Sandburg

Patent Settlements: FTC Gets Teva To Eschew 'No-Authorized Generic' Deals

Global settlement resolves charges against Teva in three pending FTC antitrust suits and expands terms of 2015 consent decree.

Generic Drugs Policy

Can Government Petition PTAB To Review Patents? Supreme Court Seems Skeptical

Justice Sotoymayor suggests 'the deck is stacked' against private citizen who is dragged by government into AIA's post-grant review proceedings. Court denies petition seeking to revive Maryland's anti-price gouging law.

Legal Issues Intellectual Property

Regenerative Medicine Therapies: Manufacturing Changes May Not Impact RMAT Designation

Final guidance notes that preliminary clinical evidence may come from studies conducted outside the US, says historical controls may be considered in clinical trial designs.

Clinical Trials Manufacturing

Commercial, Reimbursement Hurdles Need To Be Addressed By Antimicrobial Resistance Efforts

Melinta describes difficulties launching its new antibiotics at BIO CEO & Investor Conference; companies and other stakeholders urge Congress to enact package of incentives to reinvigorate antibiotic pipeline.

Infectious Diseases Reimbursement

Commercial, Reimbursement Hurdles Need To Be Addressed By Antimicrobial Resistance Efforts

Melinta describes difficulties launching its new antibiotics at BIO CEO & Investor Conference; companies and other stakeholders urge Congress to enact package of incentives to reinvigorate antibiotic pipeline.

Infectious Diseases Commercial

Rare Diseases: US FDA Gives More Guidance On Premarket Safety Evaluation, Historical Controls

Agency specifies several approaches to augment safety assessment in a new draft guidance, which also encourages participation by patients and their advocates in the drug development process.


Rare Diseases Drug Approval Standards
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