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FDA Pharmaceutical and Medical Device Headline News


China, India Fine-Tuning GMPs as API Makers Rush to Meet New EU Rules

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
 

FDA Invites Industry Feedback on BLA Submissions, IND Reporting

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
 

FDA: Devicemakers Should Consider Hacking Risks During Device Design

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cybersecurity controls and a traceability matrix linking the controls to the risks they mitigate, according to a draft guidance.Read More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 Device Regulations: Little Support for PMA; Mandatory Liability Coverage Proposed

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
 

House Lawmakers Promise to Pursue Shielding User Fees from Sequestration

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
 

Canada Launches Public Trial Database, Finalizes Guidance on Gender Selection

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

Unapproved Quality Methods Land Sandoz Subsidiary An FDA Warning

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
 

Industry Questions Lawmakers on Reports of PTO Fee Diversions

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
 

NICE Takes Over UK Medtech Adoption Program, Plans Innovation Briefings

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
 

FDA Inspection Flap Prompts Alexion Risk Assessment Reform

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

Brazil Moves to Streamline GMP Certificates, International Standards

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
 

PET Drugmaker Gets 483 for Lack of Detail and Hairnets

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 Warning Cites Process Validation, CAPAs

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
 

FDA Proposes Pathogens Hit List, Seeks Post-GAIN Act Incentives for New Antibiotics

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
 

ENVI Adopts Clinical Trials Regulation, Moving It Closer to Plenary Vote

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
 

Sigma-Tau, Validus Get Untitled Letters for Marketing Claims

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
 

FDA: Releasing More Trial Data Could Speed Medtech Development

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
 

EC Seeks Scientific Input on Scope, Safety of Synthetic Biology

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
 

Case Closed? Government Withdraws Plan B Appeal, Allows OTC Sales

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
 

OTC Drugmaker Chided for Missing Quality Actions

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

CorePharma Satisfies FDA Batch Investigation Concerns

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
 

UDI Final Rule Takes Industry Advice, But Will Still Pose Challenges: Experts

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
 

MHRA Seeks Input on Approach to EU Animal Tissue, eLabeling Regulations

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
 

AVEO Gets Complete Response Letter for Tivozanib

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

Whitepaper Urges Drugmakers to Improve Supply Chain Security

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
 

DTC Marketing Study Implies Doctors Overprescribe Statins

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
 

House Subcommittee Low Balls FDA on Budget Request

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
 

France’s ‘Sunshine’ Law Sees Daylight; Disclosures Retroactive to Jan. 1, 2012

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
 

Drug Industry Seeks Clarity on FDA Biosimilar User Fees

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
 

PET Drugmaker Gets 483 for Lack of Detail and Hairnets

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
 

FDA Considers Availability of Masked and De-Identified Data

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
 

FDA Sees Role in LDT Regulation, But Industry’s Not So Sure

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

Industry: ATMP Reg Lacks Flexibility for Evaluating Non-Drug Components

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
 

FDA Joint Panel Recommends Relaxing Avandia Restrictions

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
 

Form 483 Prompts API Maker to Question its Pharma Future

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