Top Drug Stories

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) unveiled a new anti-counterfeiting strategy that builds off a 2007 strategy with increased international collaborations to fight the expanding risk of fake drugs online.Read More

Clinical trial stakeholders must look for opportunities to join forces on larger, more meaningful studies to boost trial efficiency, a Duke University researcher says.Read More

Three Senators are urging the FDA to end generic labeling preemption and allow generic-drug makers to make safety changes to product labeling even if it will no longer mirror the brand-drug label. Read More

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is taking issue with an EU plan to scan all drugs at the point of dispensing, saying the cost of providing scanners at all healthcare outlets is too burdensome.Read More

A global treaty is needed to galvanize the necessary resources to combat elusive criminal networks counterfeiting drugs.Read More

NDA and BLA supplements have created more headaches for pharma companies than standard new drug or biologic applications, finds a new study from the Tufts Center for the Study of Drug Development.Read More

Sen. Richard Blumenthal (D-Conn.) March 29 called the U.S. Food and Drug Administration’s (FDA) response to drug shortages “inadequate,” saying lawmakers need to give the agency more tools and mandates to correct the issue. Read More

To boost biopharma innovation and U.S. competition in the sector, the FDA should incentivize precompetitive industry collaborations, promote public-private partnerships and wrap up integration of its information technology (IT) systems, a new Obama administration paper states. Read More

The House Energy and Commerce Committee will vote on an omnibus FDA user fee bill today as lawmakers hurry to move it toward enaction well before the current iteration of the Prescription Drug User Fee Act (PDUFA) expires on Sept. 30.Read More

A Medicines and Healthcare products Regulatory Agency work group is developing proposals for streamlining the UK’s over-the-counter drug reclassification process, and plans to release updated guidance on the subject later this year, according to an MHRA report.Read More

Congress and the U.S. Trade Representative need to do more to protect American biopharma patents abroad, an intellectual property (IP) expert tells Congress. Read More

The House has updated its draft of omnibus FDA user fee legislation with much-anticipated language on supply chain safety.Read More

Members of the East African Community (EAC) and public and private international aid organizations March 30 launched an initiative to promote harmonization of drug registration in Kenya, Uganda, Tanzania, Rwanda and Burundi.Read More

Citing a global surge in the use of vaccines, CBER is launching a new initiative to ramp up global pre- and postmarket vaccine pharmacovigilance.Read More

Ongoing remediation at Hospira’s Rocky Mount, N.C., plant is on track with the aid of new hires and consultants, the company says. Read More

Singapore’s Health Sciences Authority (HSA) and Malaysia’s National Pharmaceutical Control Board (NPCB) will exchange drug registration assessment reports and conduct joint inspections of manufacturing plants under a March 27 memorandum of understanding.Read More

An FDA final rule with stronger restrictions on the work of disqualified trial investigators will take effect May 30 and nearly mirrors an April 2011 proposed version that received little stakeholder feedback.Read More

The FDA has seen a dramatic uptick in early shortage notifications from drugmakers, and a drop in the number of drug shortages, in the six months since President Barack Obama ordered the agency to require more action from industry.Read More

Patent reform legislation approved by the Australian Parliament March 20 establishes a higher standard for assessment of invention and innovative steps, provides for a new “utility” requirement that requires “specific, substantial and credible use” for a claimed invention and includes more stringent requirements for the scope and detail of disclosure required to support patent claims.Read More

A new government report has cast doubt on the FDA’s ability to handle information associated with the rising flood of drug imports, saying its sluggishness in integrating legacy IT systems is limiting regulatory effectiveness.Read More

The FDA may need to better align its regulations with those of key trading partners, a move that could benefit the increasingly global drug industry, thanks to a new executive order (EO) signed by President Barack Obama Tuesday.Read More

Members of the East African Community (EAC) and public and private international aid organizations March 30 launched an initiative to promote harmonization of drug registration in Kenya, Uganda, Tanzania, Rwanda and Burundi.Read More

While CDER is improving its drug safety efforts by giving equal weight to pre- and postmarket analysis, the center’s safety science is still evolving and may potentially include wireless technologies to transmit point-of-care data, a new FDA report states.Read More

The FDA needs to take an ongoing, lifecycle approach to assessing the risk-benefit profiles of new drugs and should seek more public input during the process, a new Institute of Medicine (IOM) report urges.Read More

A Medicines and Healthcare products Regulatory Agency work group is developing proposals for streamlining the UK’s over-the-counter drug reclassification process, and plans to release updated guidance on the subject later this year, according to an MHRA report.Read More

All drugmakers need a social media policy regardless of whether they have an active presence in the online world or not, experts at the Food and Drug Law Institute’s annual conference advise.Read More

While the FDA generally met its performance goals for both priority and standard NDAs and BLAs between fiscal 2000 and 2010, the amount of time it took the agency to review those applications has slightly increased, according to a Government Accountability Office (GAO) report.Read More

Roughly 8 percent of clinical trials inspected by Health Canada between 2004 and 2011 failed to comply with agency regulations, according to a new report.Read More

The U.S. District Court for the District of Columbia has denied ViroPharma’s motion for a temporary injunction to require the FDA to withdraw its approval of three generics of the gastrointestinal antibiotic Vancocin.Read More

To boost biopharma innovation and U.S. competition in the sector, the FDA should incentivize precompetitive industry collaborations, promote public-private partnerships and wrap up integration of its information technology (IT) systems, a new Obama administration paper states.Read More

The European Medicines Agency (EMA) has published question-and-answer guidance on marketing applications for biosimilars, providing advice on a number of pre-submission issues, such as requesting an accelerated assessment, and giving detailed answers about review timing.Read More

Democrats in the House and Senate have introduced companion bills that would allow generic-drug makers to update safety warnings on labeling without waiting for the brand drugmaker to do it first.Read More

Senate appropriators overwhelmingly approved a fiscal 2013 spending bill that provides $2.5 billion for the FDA, including $10 million to fund an expansion of the agency’s China office.Read More

Democrats in the House and Senate have introduced companion bills that would allow generic-drug makers to update safety warnings on labeling without waiting for the brand drugmaker to do it first.Read More

The FDA must develop a clear and unambiguous definition of crude heparin in light of inconsistent and confusing uses of the term in its draft guidance, Merck says.Read More