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Asia Executives To Watch: New FDA China Director Named Amid ICH Push

The US FDA has sent its country director from Peru to build a closer relationship with the China FDA, while the CFDA's own medical device center is also going through a series of leadership changes.

China Appointments Asia Pacific

FDA Getting Reg Slashing Directive In Trump Executive Order

Draft order wants "comprehensive review" to find regulations that that "unnecessarily increases expenses" for patients, researchers, and manufacturers.

Pricing Debate Generic Drugs FDA

FDA Tussles With Combination Products, Fires Up Oncology Center Of Excellence

FDA officials discuss difficulties dealing with complex combination products, the future of the agency's Centers, and promotion of industry collaboration at DIA meeting.

Regulation FDA Drug Review

EFPIA Calls For Interim Accords To Ease Brexit Impact

As the first day of Brexit talks highlighted how lengthy and complex the negotiations over the UK’s departure are going to be, Europe’s drug makers are pushing for transitional measures to be in place to keep disruption to regulation and health care to a minimum.

Europe Brexit Regulation
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Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

Best Of BIO: Policy & Regulatory Updates From BIO 2017

Antibiotic incentives, vaccine strategies, drug pricing, patent updates and more hot topics from the Biotechnology Innovation Organization's recent annual conference.

ImmunoOncology Market Access Reimbursement

Latest From Regulation

Biosimilars In EU: From 'New Mess' To Beacon For Safety

Finnish Medicines Agency's Ekman says neither regulators nor industry knew what to do when the biosimilars regulatory framework was first introduced, but there haven't been any differences in adverse events between biosimilars and their reference products.

Biosimilars Drug Safety

US FDA Updates Clinical Trial e-Reporting, e-Signature Guidance To Keep Up With Tech

In a draft guidance on electronic signature and record requirements for clinical trials used to submit applications across FDA product centers, the agency responds to technological advances since it last issued guidelines almost 15 years ago, while keeping its narrow enforcement of the "Part 11" rules in place.

Clinical Trials Research & Development

FDA’s Definition of Statistical Significance: P=.05 – ish

FDA’s approval of Portola’s anticoagulant Bevyxxa is the latest reminder that the conventional standard for statistical significance, p=.05, is not a “pass/fail” standard. Even if the agency itself sometimes acts like it is.

Drug Approval Standards Regulation

Latest From Policy

Chief Scientist At US FDA Is Hinton As Borio Moves To White House

Luciana Borio is detailed to National Security Council; FDA promotes Denise Hinton to acting chief scientist.

FDA Policy

Trump Exec Order On Drug Costs: Seeking To Balance Access, Innovation

Draft version of order signals a focus on insurance benefit design, accelerating drug approvals and de-regulation.

Pricing Debate Market Access

White House Mulls Proposal To Pause FDA's Quality Metrics Initiative

Trump administration briefing materials show that the pharmaceutical industry's complaints about FDA's quality metrics initiative are getting high-level attention.

Quality Manufacturing

Clinical / R&D Explore this Topic

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Latest From Research & Development

US FDA Updates Clinical Trial e-Reporting, e-Signature Guidance To Keep Up With Tech

In a draft guidance on electronic signature and record requirements for clinical trials used to submit applications across FDA product centers, the agency responds to technological advances since it last issued guidelines almost 15 years ago, while keeping its narrow enforcement of the "Part 11" rules in place.

Clinical Trials Research & Development

Was PD-L1 Test To Blame For Failure Of Bristol's Opdivo In '026 Trial?

NEJM editorial suggests that differences in PD-L1 testing may explain why Bristol's Opdivo failed in first-line lung cancer trial whereas Merck's Keytruda succeeded, but some analysts aren't so sure.

ImmunoOncology Clinical Trials

US FDA 'Medical Innovation Development Plan' Outlined By Gottlieb

Testifying before Senate subcommittee, FDA commissioner put his plans for facilitating new drug development front and center, a shift from his many past discussions about generic drug development.

Drug Approval Standards Rare Diseases

Commercial Explore this Topic

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Latest From Commercial

Prestige Brands Updates PediaCare NDC Information A Year After Sale

The OTC drugs and personal care products company will correct Structured Product Labeling information in the US NDC Directory for PediaCare Children’s Plus Multi-Symptom Cold and Children’s Plus Flu to include one of the products' active ingredient, phenylephrine.

Commercial Regulatory

Value & Pricing Perspectives From ASCO, In Brief

Round-up of commentary on oncology drug value and costs during the American Society for Clinical Oncology annual meeting, including value frameworks, ways to lower drug costs and payer data.

Pricing Debate Health Technology Assessment

Coppertone ‘Assurance Assessment’ Anticipates Criticism From Sunscreen Reviews

Bayer shares results from a consulting firm's assessment of its operations, procedures and testing at the root of Coppertone SPF claims and other labeling aspects. The firm could get in front of a conversation that tends to arise this time of year regarding sunscreen safety, effectiveness and truthfulness in marketing.

Commercial Business Strategies

Manufacturing Explore this Topic

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Latest From Manufacturing

FDA Offers To Expedite 'Priority' ANDA Reviews By Previewing Facility Information

An FDA guidance lists the criteria for reviewing “pre-submission facility correspondence” that permits expedited approval of priority generic drugs by allowing facility information to be reviewed prior to the submission of an ANDA. This mechanism was established by GDUFA II.

Manufacturing Quality

White House Mulls Proposal To Pause FDA's Quality Metrics Initiative

Trump administration briefing materials show that the pharmaceutical industry's complaints about FDA's quality metrics initiative are getting high-level attention.

Quality Manufacturing

Pfizer’s EPO Biosimilar Stalls In US On Hospira Compliance Woes

US FDA hands Pfizer its second complete response letter for its proposed biosimilar to Epogen/Procrit, citing manufacturing compliance concerns at a legacy Hospira manufacturing facility in Kansas that was the target of a February warning letter. Issue “is not directly related to EPO itself,” Pfizer’s Salomon Azoulay says.

Biosimilars Complete Response Letters

Consumer / OTC Drugs Explore this Topic

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Latest From Consumer

Perrigo Predicts Upturn On OTC Private Label Breadth, Depth And Bandwidth

Perrigo counts on its OTC private label dominance to thwart new store brand entries and give it a leg-up in e-commerce sales, which are growing at 50% year-to-year. Private label is "a distinctly different business than the national brand space," says consumer health executive Jeffrey Needham.

Consumer Prescription To Otc Switch

Oral Contraceptive Switch Advocates Reject User Age As Approval Factor

FDA could soon receive an NDA from non-profit research group Ibis Reproductive Health and HRA Pharma, for an oral contraceptive switch in the US.

Prescription To Otc Switch Consumer

States Ease Access To Oral Contraceptives Despite Rx Requirement

Changes range from allowing pharmacists to prescribe the drugs to requiring insurers to insurers to cover purchases of the products.

Prescription To Otc Switch Consumer
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