In this week’s news, non-branded drug firms want clarity on proposed ANDA cover letter rules, device firms want more info on planned software guidelines and more.

US FDA needs to align visible particle categories with USP, says industry

Industry groups want the US FDA to align its rules on “visible particles” in injectable drugs with categories set out in the US Pharmacopoeia.

The request for alignment concerns US FDA draft guidelines on the development and implementation of particle control programs for injectable products.  

The International Society for Pharmaceutical Engineering (ISPE), Boehringer Ingelheim and Novartis were among those asking the agency to align its guidance with the USP’s Chapter 1790, specifically on classification categories and inspections.

Generics sector seeks more info on proposed ANDA cover letter rules

Generic drug makers are concerned about what will happen if they do not comply with “optional” requirements in proposed US FDA rules for product cover letters.

Various industry groups detailed their concerns last week, with several seeking confirmation about whether optional attachments in draft guidelines are truly a choice. 

For example, the Association for Accessible Medicines (AAM) took issue with the statement that, although the attachments are optional, they will help ensure that “submissions are effectively managed” and “acted upon by their performance review goal dates.”

 The AAM wrote “Applicants will likely feel compelled to provide the attachments for fear that, otherwise, their submissions will not be properly managed within the user fee goal dates or will be otherwise disadvantaged.”

Drug and device sector wants clarity of device software guidelines

The Advanced Medical Technology Association (AdvaMed) has asked the US FDA to rejig its draft guidelines on device software while GE Healthcare has called for “clarity.”

The draft guidelines – which were issued by the FDA in November – state the agency will determine which software running on a medical device needs to be accompanied by a basic or enhanced level of documentation. 

The agency will base its determination on the potential risk posed by the device, whether it is intended to test blood donations, or whether it is used to determine donor and recipients compatibility.

The AdvaMed took issue with this, writing “simply because a software function may be a constituent part of a combination product, used with blood screening assays, or a component of a class III device, does not mean that the software contributes significantly to the overall risk of that device.”

GE Healthcare, meanwhile, suggested that the FDA should more fully explain how the basic or enhanced level of documentation requirement is determined.

 

Also in the news…

The Wall Street Journal reported that the US Department of Commerce has added Wuxi Biologics to its “unverified list” in connection with the CDMO’s efforts to import hardware controllers for bioreactors and hollow fibre filters from suppliers in the US.

According to Bioprocess Insider, disruption caused by COVID-19 prevented US agents conducting end-use verifications at various Wuxi facilities. See full Wuxi statement.

Brookings took a look at the state of pharmaceutical manufacturing across Africa in a new report.

Endpoints covered Skyepharma’s role in the production of microbiome therapies for MaaT Pharma. The plan is to build the largest specialized manufacturing facility for microbiome-based therapeutics. 

The Pink Sheet looked at US FDA plans to include more information about excipients in drug labelling.

 

CDMO trends

Some developments of note in the contracting sector:

Piramal Pharma plans to expand ADC production capabilities at the Grangemouth facility in Scotland and its API infrastructure at its plant in Morpeth, England. 

MilliporeSigma, the US and Canada Life Science business of Merck KGaA, plans to rejig its business into three divisions to strengthen its CDMO business.

The US Department of Defense (DOD) has awarded Ology Bioservices a $250 million contract for manufacturing development of a monoclonal antibody against botulinum neurotoxins (BoNT).

Berkshire Sterile Manufacturing has added formulation, lyophilization and method development capabilities at its facility in Lee, MA.

Humanigen has made Cenexi a preferred supplier of lenzilumab in France and the European Union, under a new agreement.

 

You might also be interested in…

STAT discusses the miracle of COVID-19 vaccines from the development, testing, manufacturing and global distribution standpoints. 

Biopharmadive spoke on how biotechs are taking longer to raise money and so-called “crossover” investors may be resetting their expectations.

Endpointnews published an article on how FDA has restarted domestic drug manufacturing inspections.