Pharma employees who report manufacturing misconduct to stop adulterated drugs getting to market put their careers at risk and face being blackballed by industry says an American advocacy group.
Biosimilar developers such as Mylan and Pfizer are taking issue with FDA draft guidance that in some circumstances could extend biosimilar development timelines and discourage their development.
Some Chinese firms wont have the 'written confirmations' required to ship APIs to the EU from July according to the German audit firm tasked with helping manufacturers prepare by Beijing industry group, CCCMHPIE.
Failure to clean up unsanitary conditions at a US plant and address cGMP violations at a facility in Puerto Rico have earned Baxter another warning from the US FDA.
Japan has become the third country outside the EU to be exempt from providing written confirmation that APIs imported into Europe have met required standards when legislation commences on July 2nd.
Impax Laboratories says it remains committed to resolving manufacturing issues at its troubled Californian plant though 110 jobs will go as production continues to be transferred to Taiwan.
The Commissioner of the FDA says laboratory-developed diagnostic tests needs to be regulated for clinical validity to stop erroneous results and ensure patient and clinician confidence.
As propofol comes off its shortages list, the FDA says manufacturing problems still cause the majority of supply issues though legislation has helped to alleviate this.
The US House of Representatives has passed a bill by voice vote that would for the first time create a system to track and trace drugs through the supply chain.
USP has decided to delay the implementation of two general chapters on elemental impurities until ICH has further established its own impurity testing requirements.
Fresenius Kabi says drug shortages won’t be affected as it recalls a lot of magnesium sulphate, and there’s news from Glenmark and J&J – welcome to in-Pharmatechnologist.com's recall round-up.
As new API regulations are set in July for those outside the EU, the European Medicines Agency (EMA) has unveiled what its inspectors expect to see from API manufacturer or supplier audit reports from inside the region.
Pfizer and other EU industry and academic groups are calling on the European Commission to revise its plans for authorizing and regulating ATMPs (advanced therapy medical products).
Though Janssen Korea says it is confident it will resolve its manufacturing issues, product recall and suspensions could be followed by lawsuits and imprisonment.
Regulators and the drug industry met in Moscow last week to develop a framework for firms developing biologics and biosimilars in the Russian Federation.
New UK proposals to label all drugs as “produced as a result of research on animals” have met with muted response from pharmaceutical industry group, the ABPI.
The US House Energy & Commerce Committee on Wednesday advanced a bill to further secure the US prescription drug supply chain, though it stops short of mandating unit-level, electronic tracking and tracing of drugs.
Differences in elemental impurity standards being developed separately by the US Pharmacopeia and ICH could mean costly reformulations according to a pharmaceutical, API and excipient industry coalition.
Looking to align with other industrialized nations, Canada has agreed to extend its GMP requirements for all active pharmaceutical ingredients (APIs), according to a notice in the Canada Gazette.
In the war against counterfeits, regulators have concentrated on serialisation and ePedigree and missed an opportunity on product authentication, according to AlpVision.
Revised excipient guidelines expected from Brazilian regulator Anvisa this year will reduce confusion and further align standards with those in the US and EU says an industry expert.
China’s implementation of GMPs for excipient manufacturers, as well as a developing US FDA-style DMF system, have added another layer of safety requirements but challenges remain for the regulators in ensuring compliance, experts say.
International GMP standard facilities and six biopharma centres will lead Russia’s initiative in implementing its Pharma 2020 policy, according to statements at this year’s BIO International Convention.
Purification bottlenecks, integrating single-use technologies and low cost companies are just some of the issues affecting the biotech industry today, according to experts at this year’s Interphex.
A clear timeline and stepwise approach to a US solution for tracking and tracing pharmaceuticals through the supply chain to root out counterfeits is necessary, stakeholders agreed.
Efforts to update SUPAC guidance on immediate and modified release dosage forms will end in faster approvals, if regulatory and financial hurdles can be overcome, says expert.
The US FDA is beginning to push CMOs and other manufacturers away from using real-time release testing as a shortcut to ensuring drug quality and reducing end product testing, experts said.
A new bipartisan draft bill released by four US senators late last week seeks to establish a lot-level electronic system to track pharmaceutical products and further secure the US supply chain.
The FDA has finalised guidance on the manufacturing of antibiotics in order to prevent cross-contamination of finished pharmaceuticals and APIs with non-penicillin beta-lactam drugs.
The EMA’s upgrade to the EudraGMDP database aims to increase the safety of the EU supply chain by releasing GMP certificates and other data so companies can ensure supplier compliance.
The inventor of a reagent recently found to be highly explosive says many drug production chemicals may have similar profiles and that knowing how to handle them is the key.
Biostar Pharmaceuticals has blamed end-of-year losses on last year’s chromium-tainted gelatin scandal though it is slowly recovering following a suspension of sales enforced by the SFDA.
One day after Purdue Pharma’s blockbuster opioid OxyContin lost its first patent, the US FDA has amended the drug’s label and now requires generic drugmakers to adopt similar abuse-deterrent formulations.
US officials' new take on import rules may mean APIs destined for trials will only be allowed into the country if they are listed in an effective IND application, according to Clinipace QA chief Nikolas Burlew.
President Obama’s FY 2014 budget request of $4.7B for the US FDA would increase the agency’s ability to inspect foreign drug manufacturers and clinical trial sites.
The manufacturing sites of Alexion Pharmaceuticals and Italy-based Wyeth Lederle S.p.A were cited in FDA warning letters for cGMP (current good manufacturing practice) violations in their production of APIs and finished pharmaceuticals, respectively.
India’s Directorate General of Foreign Trade (DGFT) has pushed back the deadline again for adopting new barcodes to track pharmaceutical exports by one year.
Recent changes to EU drug risk-benefit reporting rules mean more work for multinational Pharmas but are still an improvement on ‘old-style’ PSURs says EFPIA.
The EMA has changed how it monitors the risk-benefit profile of marketed drugs, adopting a single assessment that includes a broader range of API safety reports.
