In this week’s news, FDA drug review rejig OKed, MHRA updates on safety monitoring post Brexit, US changes view of Apps as medical devices and more…
US politicians OK FDA drug review modernization plans
The US Congress approved plans to reorganise the US FDA office of new drugs last week, in a decision that will also impact the agency’s translational sciences and quality offices.
According to the FDA the reorganisation will establish offices for linked disease areas each with more focused expertise. Two new review divisions will be established, while the number of clinical divisions will grow from 19 to 27.
Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “Modernising our operations helps us perform our mission effectively in an environment of rapidly evolving science, changing stakeholder expectations, and new statutory authorities and responsibilities.
“The new structure will strengthen operations in a number of CDER offices and will allow the FDA to better meet the evolving needs of new drug review” she said.
See more from RAPS.
No-deal Brexit would change pharmacovigilance requirements, says UK MHRA
Post market drug safety monitoring rules will change if the UK crashes out of the EU next month according to the MHRA.
The regulator set out how a no-deal Brexit would impact pharmacovigilance last week, explaining some EU GVP provisions “will no longer apply to the MHRA and UK MAHs or are to be read subject to modification.”
Most of the changes relate to UK laws that will replace EU rules on exit day. It also covers instances where references to “competent authorities” in Marketing Authorisations will be switched to the UK licensing authority.
The regulator also states that guidance issued by the European Commission under Article 108a of 2001/83/EC “continues to apply” to both MHRA and UK MAHs until the UK publishes its own GVP guidance.
See the full guidance note here.
US FDA clarifies which Apps are medical devices
The US FDA has published a list of smartphone applications – apps – it no longer considers to be medical devices.
The Agency detailed the changes last week, explaining they were prompted by the 21 Century Cures Act which revised the definition of a medical device.
As a result calorie counting apps and those that let people log workouts or food consumption are no longer considered to be devices.
The FDA wrote, “Many software functions are not medical devices, and FDA does not regulate them as devices. Some software functions may meet the definition of a medical device, but because they pose a lower risk to the public, FDA intends to exercise enforcement discretion”
Read the FDA statement here.
Also in the news
DCAT examined the impact trade disputes – including the US’ current disagreement with China – will have on global pharmaceutical supply lines.
Pfizer will relocate its gene therapy manufacturing activities to a new facility in North Carolina. See the Bioprocess Insider story for more details.
Some developments of note in the contract manufacturing sector:
Permira’s acquisition of Cambrex looks set to go ahead following the expiration of the “go shop” period last week. Eight potential bidders entered into a confidentiality agreement with Cambrex, however, no alternative acquisition proposals were forthcoming.
Minerva Neurosciences has hired Catalent to make its schizophrenia drug roluperidone. Catalent will manufacture and package the finished dose form of the drug at its facility in Schorndorf, Germany.
Pii will make commercial supplies of the hormone therapy Fulvestrant Injection 250mg/5ml drug product in a deal with Sagent Pharmaceuticals.
Transcelerate Bio has hired AMRI to help make its candidate mRNA based therapies. Under the deal AMRI will build dedicated cGMP clinical manufacturing suites. See press release.