FDA Pharmaceutical and Medical Device Headline News

China and India are working to help local manufacturers of active pharmaceutical ingredients satisfy the tough, new quality requirements in the EU’s Falsified Medicines Directive.Read More

The FDA is seeking industry comment on the litany of requirements for submitting BLAs, to gauge how burdensome the requirements are and if they can be streamlined.Read More

Premarket submissions for internet-connected medical devices should include cybersecurity risks considered during the product design, established cybersecurity controls and a traceability matrix linking the controls to the risks they mitigate, according to a draft guidance.Read More

EU lawmakers seemed lukewarm, at best, on the idea of subjecting the riskiest medical devices to a U.S.-style premarket approval mechanism during a May 29 debate by members of the Committee on the Environment, Public Health and Food Safety.Read More

An industry effort to protect user fees from sequestration got a major boost Thursday as House leaders vowed to take up the issue in future budget negotiations with the Senate.Read More

The Canadian government has established a new public database of authorized clinical trials.Read More

Sandoz subsidiary Ebewe Pharma has been warned for distributing parenteral drug products to the U.S. that were made using quality control methods not included in an approved application.Read More

AdvaMed, the Medical Device Manufacturers Association and other groups are questioning lawmakers about reports that the Office of Management and Budget is diverting patent application fees to general government spending to help mitigate sequester effects.Read More

The UK’s National Institute for Health and Clinical Excellence on May 1 took over the National Health Systems’ technology adoption program, ensuring a “more seamless and effective route” to the adoption of novel diagnostics, surgical implants and other devices.Read More

Alexion is reviewing its analytical methodologies and procedures to ensure its risk assessments meet the FDA’s expectations, the drugmaker said.Read More

The prospect of a standardized single audit program for medical devices, currently being developed by the International Medical Device Regulators Forum, is fueling efforts by Brazil’s Anvisa to bring device good manufacturing practice regulations in line with international standards, an expert says.Read More

Cardinal Health, which manufactures positron emission topography (PET) drugs at a Tampa, Fla. plant, received a Form 483 for thin investigations into batch failures.Read More

Edwards’ Draper, Utah, facility received a lengthy warning letter related to the company’s cardiac surgery systems products, with observations on design and process validation, CAPAs, finished device acceptance and packaging.Read More

The FDA on Wednesday published a list of proposed “qualified pathogens” it believes most endanger the public and might be eligible for qualified infectious disease product designation under the GAIN Act provisions of the FDA Safety and Innovation Act.Read More

The European Parliament’s public health committee May 29 adopted draft rules calling for simplified clinical trial reporting procedures and enhanced authority for European Commission inspections.Read More

The FDA last month handed untitled letters to Sigma-Tau Pharmaceuticals and Validus Pharmaceuticals for downplaying risk information in marketing materials — a problem the agency last week urged consumers to look out for in an educational consumer alert.Read More

The FDA is considering making more masked and de-identified safety and efficacy data from clinical and preclinical trials available to boost opportunities for innovative development of medical products.Read More

The European Commission is seeking input from its scientific committees on the relationship of synthetic biology (SB) to the genetic modification of organisms, its implications for human health and the major gaps in knowledge necessary for performing a reliable risk assessment.Read More

In a surprise move late Monday, the Obama Administration said it will make Teva’s Plan B One-Step available for sale over-the-counter without age or point-of-sale restrictions, ending its appeal of New York Federal Judge Edward Korman’s April 5 ruling in Tummino v. Hamburg.Read More

Oxygen Development received a Form 483 for not performing certain key quality control procedures.Read More

Generic drugmaker CorePharma created a successful formula for quality control, prompting the FDA on May 3 to close out the company’s June 2010 warning letter.Read More

Industry will get much of what it asked for in the unique device identifier final rule, which is expected to be released around its June 19 deadline.Read More

The UK’s Medicines and Healthcare products Regulatory Agency is seeking views on its approach to implementing the European Commission’s regulations on use of animal tissues in medical devices and electronic labeling.Read More

The FDA has rejected AVEO’s kidney cancer candidate tivozanib in line with an advisory committee’s recent recommendations.Read More

Google searches, detailed contracts and audits-a-plenty: This is the recipe that one expert industry working group asks drugmakers to follow to guard against illegal drug diversion.Read More

A new study on direct-to-consumer (DTC) marketing of statin drugs suggests the prevalence of such ads promotes over-diagnosis in patients that may not be at risk for cardiac events.Read More

A House subcommittee Wednesday voted to advance appropriations legislation boosting the FDA’s fiscal 2014 funding by nearly $100 million over post-sequester levels, but the budget bill doesn’t come close to meeting the agency’s initial $4.7 billion request.Read More

Beginning this month, devicemakers in France must begin reporting all payments and other benefits to healthcare professionals in excess of €10, including tax — about US $12.87.Read More

Drugmakers used comments to an FDA draft guidance on formal agency meetings for biosimilars to push for clarity on biosimilar user fees, with one company, Mylan, arguing the fees should be lower than those paid for drugs beholden to PDUFA requirements.Read More

Cardinal Health, which manufactures positron emission topography (PET) drugs at a Tampa, Fla. plant, received a Form 483 for thin investigations into batch failures.Read More

The FDA is considering making more masked and de-identified safety and efficacy data from clinical and preclinical trials available to boost opportunities for innovative drug development.Read More

An FDA move for stronger oversight of laboratory-developed tests (LDTs) is facing significant industry pushback.Read More

Six years after the EU’s advanced therapy medicinal products regulation went into effect, only one tissue-engineered product has been granted approval, Eucomed says in comments criticizing the regulation’s approach to the evaluation of ATMP products.Read More

A conflicted joint FDA advisory committee voted Thursday to ease restrictions on sales of GlaxoSmithKline’s (GSK) diabetes drug Avandia but stopped short of recommending removal of the drug’s strict risk evaluation and mitigation strategy (REMS) program.Read More

Ames Goldsmith is speculating whether to remain an active pharmaceutical ingredient (API) manufacturer after the company received a Form 483 for documentation issues, some of which were repeats.Read More