FDA published its long awaited draft guidance for industry, ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers, in the Federal Register August. 27, 2013. The document provides answers to questions submitted during the public comment period on the draft stability guidance that was published on September 25, 2012. The final guidance for industry was published on June 20, 2013. The question-and-answer draft guidance document is open for comment for the next 60 days.
From The Corner Lab - Blog Posts
The International Conference on Harmonization (ICH) has started the consultation period on elemental impurities. ICH Q3D - Impurities: Guideline for Elemental Impurities - laying out limits for metallic impurities in pharmaceutical ingredients and preparations and detailing the testing procedures used to detect and measure them. With the July 26, 2013 issuance of the guideline, Q3D has now entered step 2b of a five-step implementation process. There is a six-month comment period which gives the industry and other stakeholders time to forward their comments.
The US Food and Drug Administration (FDA) has released a new 2 page guidance for industry that pertains to stability testing recommendations for generic drug products submitted under 505(j) of the Federal Food, Drug and Cosmetic Act (FD&C Act) as an abbreviated new drug application (ANDA) or a drug master file (DMF).
Proposed revisions for General Chapters <232>, <233>, suggested for a May 1, 2014 implementation date, has been deferred. As such, there is no requirement for ANY drug product in the USP-NF to comply with the proposed USP <232>, <233> at this present time.
A new Virginia law is the first in the country that would prevent the automatic substitution of non-interchangeable biosimilars. Pharmacists substituting an interchangeable biosimilar for a brand product would need to inform the patient prior to the switch. Amgen and Genentech have been pushing state legislators to enact measures, including Virginia’s H.B. 1422, but the generic industry says such rules will create hurdles for the uptake of biosimilars.
Quantex Laboratories has completed the expansion of its GMP analytical laboratory with its relocation to a larger, state of the art facility at 3000 Eastpark Boulevard in Cranbury, New Jersey. With the new facility nearly four times the size of Quantex Laboratories’ previous site, the company is also adding microbiological testing capabilities later in the year to its contract laboratory and analytical testing CRO services.
The Drug controller general of India has moved to prohibit medicines from being sold under brand names. As a result, earlier this week, states were ordered to stop issuing licenses for the manufacture or sale of drugs under brand names This move is already raising objections from domestic drug makers. The effort is designed to accelerate the sale of lower-cost generics in India.
According to recent reports an anticipated decline in the global pig population may result is heparin shortages next year. The decline is due in no small part to the increasing costs for feed and other animal welfare costs to farmers. In the US, the on-going drought in the farm belt has had a significant impact. In response, President Barack Obama introduced a pork buying program to support the industry. A comparable plan has also been implemented in China.
With all the talk of rising prices for cancer medications, the cost of healthcare and comparing the value and benefit of competing drugs, Memorial Sloan-Kettering Cancer Center has decided not to use a newly approved treatment for metastatic colorectal cancer. The leading hospital says it will exclude the new colorectal cancer drug Zaltrap which is marketed by Sanofi and Regeneron, from its treatment protocol.
Since 1992, Merck has called Whitehouse Station, NJ home to its corporate headquarters. Now followings its merger with Schering Plough in 2009, it has decided to close and shutter the facility, relocating its headquarters and some 2,00 employees and contractors to new digs scattered around New Jersey. And the company is billing the move as a sign of its increasing corporate.