Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has set out the safety control measures it plans to implement in response to the launch of generic versions of Bristol Myers Squibb’s blood cancer drug Revlimid (lenalidomide).   The dispensing of lenalidomide Japan is covered by the RevMate control procedures because the drug molecule has a similar chemical structure to thalidomide and was shown to cause birth defects and abnormalities in animal studies. Japan’...

In a nondescript building in North Bethesda, MD, the US Food and Drug Administration (FDA) houses a cybersecurity control center responsible for protecting its digital assets. Since the beginning of the COVID-19 pandemic, the agency said it has seen a sharp uptick in cyber threats, which it said have  been successfully thwarted in part due to its recent modernization efforts.   FDA’s Cybersecurity and Infrastructure Operations Coordination Center (CIOCC) monitors, anal...

The International Council for Harmonisation (ICH) last week announced that its S12 guideline on nonclinical biodistribution (BD) considerations for gene therapy products has reached Step 4 of the ICH process, meaning it’s ready for regulators to adopt in their jurisdictions.   The guideline provides considerations for the design, timing and conduct of preclinical BD studies, and offers various recommendations for sponsors on the animal species or model to be used, the ...

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.   In Focus: US California Picks Generic Drug Company Civica to Produce Low-Cost Insulin ( KHN ) ‘A safe place to fail’: ARPA-H chief on building a culture of risk-taking in science ( STAT ) Moderna CEO made $398 million in 2022, but still pledges to give most to charity ( STAT ) FDA staff says safety issues with Biogen's ALS drug to not prevent approval ( Reuters ) Wyoming govern...

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week, FDA released more details on its FY2024 budget request, Pfizer announced it is recalling millions of packages of a migraine drug over concerns about its packaging and FDA advisors back the approval of Pfizer’s COVID-19 drug Paxlovid.   FDA’s nearly 300-page FY 2024 budget ...

While the US Food and Drug Administration’s (FDA) latest draft guidance on improving the consistency of information in the dosage and administration section of prescription drug labeling is significantly larger than an earlier guidance issued in 2010, industry stakeholders said they wanted more information from the agency on how labeling of specific cases should be handled.   FDA’s draft guidance on improving development of the dosage and administration section of drug...

The US Food and Administrations (FDA) on Thursday finalized guidance defining what constitutes suspect and illegitimate products, as well as what constitutes products that are counterfeit, diverted, stolen, fraudulent or unfit for distribution.   The guideline aims to help industry meet their verification obligations under the Drug Supply Chain Security Act (DSCSA) which requires trading partners to be able to identify a suspect or illegitimate product. The guidance ...

Three domestic drug manufacturers were chastised in recent warning letters sent by the US Food and Drug Administration (FDA) for similar good manufacturing practice (GMP) violations related to failure to test incoming components and missing validation programs to ensure products remain in a state of control.   Another problem found at two sites were lax or nonexistent stability testing programs. One company was lambasted for “filthy conditions” at its facility, includi...

The US Food and Drug Administration (FDA) has issued draft guidance on the development of local anesthetic products with a prolonged duration of effect that can last for days.   The guidance, published on 16 March 2023, is part of a larger effort to reduce the use of opioid analgesic drugs, according to FDA. “Although different local anesthetic drug products have different pharmacokinetic (PK) profiles, in general their effects last a few hours. However, the increasing...

The European Commission has published delegated regulations to change the frequency that notified bodies are reassessed under the new device and diagnostic regulations.   Under the original Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR), notified bodies designated to certify devices under the rules needed to be reassessed three years after first being notified and every four years thereafter. The need to free up time at existing MDR/IVDR no...

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.   In Focus: US FDA says Pfizer COVID pill EUA for adolescents to stay even after nod for adults ( Reuters ) ( FDA ) Biden says ‘more coming’ on drug pricing after inflation fines ( Reuters ) Abortion-Pill Challenge Hearing Ends Without Judge Ruling ( Bloomberg ) Explainer: How recent lawsuits could affect access to abortion pills ( Reuters ) US FDA Opens OTP Director Search Again...

Pharmaceutical industry stakeholders urged the US Food and Drug Administration (FDA) to better align its investigational new drug application (IND) annual reporting proposal with the International Council’s for Harmonization’s (ICH) E2F guidance on development safety update report (DSUR), especially with regard to the cut-off date for submitting annual reports.   These comments are in response to FDA’s proposed rule issued in December 2022 outlining changes to the ...