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Drug Safety

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Latest From Drug Safety

India’s E-Plan To Map Drug Sales – Turning Point For Better Traceability?

A government plan aimed at putting in place an e-platform to regulate the sale of medicines in India, is expected to bolster end-to-end traceability and help lower the risk of fake drugs in the supply chain. But the platform’s proposed revenue model appears to be a sticking point, at least for now, among other tricky areas.

Policy & Regulation Regulation

Alka-Seltzer Antacid Will 'Plop, Plop Fizz, Fizz' Without Aspirin

In advance of a US FDA advisory panel meeting on the safety of OTC monograph antacid/aspirin products, Bayer is removing aspirin from its pioneering Alka-Seltzer effervescent indigestion products. Bayer's Andre Schmidt talks about the safety advantages and consumer trends that helped spur the change.

Consumer Drug Safety

Black Triangle Scheme And Formal Inspections On the Cards In Australia

New pharmacovigilance-enhancing proposals from Australia’s Therapeutic Goods Administration signal the agency’s intention to become more proactive when it comes to monitoring drug sponsors.

Drug Safety Post Market Regulation & Studies

Opana ER Panel Urged To Disregard ‘Invalid’ Human Abuse Liability Study

In unusual public hearing, Edwin Thompson, head of the US firm that contract manufactures Endo’s long-acting opioid, tells US FDA advisory committee that intranasal ‘liking’ study violated FDA requirements. Thompson has petitioned the agency to do away with need for human abuse liability studies entirely, asserting they are inherently flawed.

Advisory Committees Drug Safety

US FDA Strategy On Abuse-Deterrent Opioids Needs Rethinking, Panelists Say

Deterring intravenous abuse over other routes of abuse should be agency's priority, some advisory committee members say during discussion of abuse patterns and risks with Endo’s reformulated Opana ER.

Advisory Committees Drug Safety

Opana ER Looking At REMS – Or Worse – After US FDA Panel Weighs Intravenous Abuse Risk

Most advisory committee members say Endo’s reformulated long-acting opioid no longer has a favorable risk/benefit profile due to increased intravenous abuse; panelists split on whether drug should be taken off market or if restrictive REMS would suffice.

Advisory Committees Regulation

Tylenol First To Move On Single Dosage For Children’s Acetaminophen

Johnson & Johnson narrows its pediatric Tylenol tablets a single 160 mg dose and other manufacturers are expected to follow suit, in line with a US FDA panel recommendation.

Consumer Drug Safety

The First LPAD? Cempra May Try New Pathway For MRSA Antibiotic, Could Retrofit Solithromycin

Cempra Pharmaceuticals appears to be one of the first companies exploring the newly enacted “limited use” pathway for novel antibiotics. The company cited the approach as an option for fusidic acid for use against MRSA – but it sounds like it may also be on the table for the company’s recently rejected solithromycin.

Drug Approval Standards Clinical Trials

Data Integrity Failures Undermine Trust That Can’t Easily Be Won Back, EMA Official Says

A forum on quality excellence in India saw global regulators highlight regulatory requirements and expectations in critical areas such as data integrity and the investigation of compliance-related complaints. The fostering of a quality culture was another key theme at the event, with one EMA speaker noting there are no easy fixes when trust in data is broken.

Regulation Drug Safety
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