FDA has pushed back goals in relation to the Prescription Drug User Fee Act (PDUFA), the Biosimilar User Fee Act (BsUFA), and Medical Device User Fee Act (MDUFA) as a result of the closing of agency offices during Hurricane Sandy. FDA says it will assess the goals that were due October 31 and extend them as needed. The extensions will be no more than the number of business days the agency was closed.
The East Coast, including PharmTech’s offices, is largely boarding up and shutting down in preparation for Hurricane Sandy. But the FDA is still keeping vigilant. Just before the weekend, on Friday, Oct. 26, 2012, FDA released a copy of a Form 483 issued to the New England Compounding Center (NECC), which has been under investigation for violating the Federal Food, Drug, and Cosmetic Act.
“The inspection report for NECC has not been completed and is not being shared at this time,” says the release. FDA is still working with the US Centers for Disease Control and Prevention and Massachusetts partners regarding fungal meningitis outbreak and those patients who received NECC’s compounded preservative-free methylprednisolone acetate (80mg/ml), an injectable steroid, according to the release.
For back story, see the video on PharmTech.com/PharmTechTV regarding the compounding center and its connection to the recent fungal meningitis outbreak.
The recent presidential and vice-presidential debates have highlighted the need for strategies for economic growth in the US, including the roles innovation and trade play in stimulating the US economy. Eli Lilly Chairman, President and CEO John C. Lechleiter recently weighed in on the issue with respect to the pharmaceutical industry in offering his perspective on the importance of including data exclusivity provisions for biologics as found in US law for the Trans-Pacific Partnership (TPP), a regional free trade pact in Asia under negotiation.
Yesterday, I reported the news that the US Pharmacopeial Convention (USP) released new standards for labels on prescription containers dispensed by pharmacists in the US. It seems that, despite the efforts of regulators, industry, and medical professionals, patients continue to misunderstand dosage instructions. Read more »
Laboratories that offer stem-cell treatments have come under close scrutiny by FDA. Read more »
Pharmaceutical Technology and Patheon are partnering to provide you—our readers—with CMC advice from some of the leading formulation scientists and pharmaceutical manufacturing experts in the world. To get started, we need to know what plagues your CMC strategies and daily work. Email your questions directly to Editorial Director Angie Drakulich at adrakulich@advanstar.com. (*Note: We will keep your name and company affiliation anonymous.)
Answers will be provided by the Patheon Certified Consultants team beginning in the January 2013 print and online editions of PharmTech. These experts have collectively brought more than 200 pharmaceutical products to market, including some of the world’s largest blockbusters.
Sample questions:
• I have a BCS Class II compound for which amorphous solubility is easily sustained, but I can’t get the compound to rapidly dissolve. What are some solutions, particularly with respect to excipient selection?
• I have a compound that is non-ionizable and does not form a stable salt. Are co-crystals my best option and what are the key criteria in identifying a suitable co-crystal?
• I am having trouble maintaining product stability when scaling up a lyophilization process. What are the likely factors causing the problem?
PhRMA Senior Vice-President Matthew Bennett released a statement today on the state of the biopharmaceutical industry, in response to an analysis in the British Medical Journal. Bennett states that while the US may be lagging behind in spurring innovation programs, he believes the passage of the Prescription Drug User Fee Act (PDUFA) will improve the situation.
Here in Boston, the crowds are bustling at the BIO 2012 Convention and Exhibition. Today, BIO unveiled survey results that polled about 170 biotech industry leaders and 800 US voters, conducted by Hart Research and Public Opinion Strategies. Approximately 63% of biotech industry leaders said that they feel “very optimistic” about the future of biotech and its ability to develop new products that will meet global needs. A similar survey was conducted in 2007 showing that 79% of industry leaders were optimistic about biotech’s future. So there is a dip in optimism here, but considering the economic downturn of the past couple of years, such a change is not surprising. Read more »
Legislation to reauthorize Food and Drug Administration user fee programs sailed through the House and Senate last month, setting the stage for leading legislators to resolve their differences and agree on a compromise measure. Much of the work will be tackled by Committee staffers who have been laboring over the legislative details for months. The aim is to bring the House and Senate leaders together in about two weeks to hash out the final language. Read more »
The world of drug development is littered with early-phase failures: drugs that were shown to be safe in Phase I trials, but which failed to show efficacy later on. The failure of a drug at this early phase might not mean that there’s anything wrong with the compound. Rather, a failure might mean that the mechanism by which the drug acts was not of benefit in the disease against which it was tested. Read more »
From PharmTech.com