Tech Talk

FDA is proposing to revise its rules to permit generic-drug manufacturers to initiate safety-labeling changes instead of waiting until the brand company takes action.

Health plans that limit drug converge may encourage consumers to obtain medicines illegally, according to pharmacy experts.

Establishing a new Office of Product Quality in the Center for Drug Evaluation and Research (CDER) is a top priority for CDER director Janet Woodcock, and she plans to take charge of the operation personally when it is established next year.

As the pharmaceutical industry prepares for changes to compendial and regulatory standards for elemental impurity analysis, QA/QC and laboratory scientists are tasked with adapting their operations to include data management, analysis, and reporting based on inductively coupled plasma–mass spectrometry (ICP–MS).

Regulatory compliance is of paramount importance to pharmaceutical and biopharmaceutical companies, which must be continually prepared for inspections by FDA, EMA, and other health authorities to meet requirements for good clinical practices (GCP) and good manufacturing practices (GMP).

Guest blog written by Walter Morris, Director of Publishing, Parenteral Drug Association, on behalf of the PDA Quality Metrics Task Force.

CPhI Worldwide and CPhI Pharma Evolution, part of UBM Live’s Pharmaceutical Portfolio, today released Part II of the CPhI annual industry report, in which expert industry panel members share their views on trends that will drive growth and innovation across the pharmaceutical industry over the coming years and beyond.

It’s Day 2 at CPhI and the remaining findings of the annual expert industry report were released today during the show. As continuous processing continues to revolutionize manufacturing, Emil Ciurczak, principal at Doramax Consulting, believes that large batch production will one day be a thing of the past.

Officials from FDA and the National Institutes of Health (NIH) were scheduled to explain developments in clinical trial registration and transparency at the Drug Information Association’s conference on Clinical Trial Disclosure in Bethesda, Md. this week.

Public outrage over deaths from contaminated injectibles produced by large compounding pharmacies, along with rising concerns about counterfeit and unauthorized drugs entering the U.S. market, managed to lift the stalemate on Capitol Hill long enough to generate agreement on reform legislation.

Healthcare spending will rise modestly in the US over the next decade, as economic growth picks up, health reform provides expanded coverage, and the population continues to age, according to an annual analysis from the Centers for Medicare and Medicaid Services (CMS).

FDA commissioner Margaret Hamburg has formed a top-level working group to propose strategies for enhancing agency functions and processes, starting with the relationship between FDA Centers and its field force.

Product quality is of paramount importance to pharmaceutical manufacturers, and implementing a strategy for impurity control is crucial.

With the increasing use of high-potency APIs, it is more important than ever to have an appropriate containment strategy to protect both the quality of your product and the safety of your personnel.

A team of scientists recently reported on the first study of interactions between the antiretroviral drug, amprenavir, and the HIV-1 protease enzyme.

The last few weeks have seen the media swamped with stories about the rampant bribery clawing the pharmaceutical industry in China.

Craig Stobie from Domino Printing Sciences shares on how to prepare for FMD and other emerging legislation.

Guest blog written by Adrian Tombling, partner and patent attorney at Withers & Rogers LLP.

We’re already embroiled in the annual speculation game about whether FDA approvals this year will keep pace with last year’s near-record of 39 new molecular entities (NMEs) brought to market.

The Food and Drug Administration may no longer be able to alleviate shortages in vital drugs by permitting the import of unapproved medicines following a decision by the US Court of Appeals for the District of Columbia.

While it may not happen often, clinical trials can sometimes be halted by patent disputes, leading to costly delays in bringing new drugs to market. At last, the UK Government has decided to do something about this in a bid to make UK patent law more consistent with that in some other parts of the world.

Upcoming requirements in the US and around the world for serialization and track and trace of pharmaceuticals were a focus of the Pharmapack conference held in Philadelphia, PA earlier this week.

Pharmaceutical companies can anticipate more costly, drawn-out patent litigation in the wake of the June 17 US Supreme Court decision, which creates great uncertainty about the grounds for negotiating settlements in patent cases.

The Supreme Court decision blocking patents on naturally-occurring genes has generated predictions of doom for biotech innovation, along with expectations of more healthy competition in discovering new treatments and diagnostics.

Quality is of utmost importance in drug development and manufacturing.

Risk and reward. It is a balance that has to be achieved in any business endeavor and is of utmost importance for pharmaceutical and biopharmaceutical companies managing their growth and manufacturing in emerging markets.

It is well known that the pharmaceutical industry spends billions each year on promoting their products, especially to healthcare professionals.

International markets play an important role in pharmaceutical and biopharmaceutical companies’ growth strategies, and it is crucial that companies meet the challenge of global regulatory compliance.