Drugmakers want clarifications on an updated draft guidance the US Food and Drug Administration (FDA) recently released on pre-submission facility correspondence (PFC) for generic drug applications.   In December, FDA revised its draft guidance on submitting PFCs for generic drug applicants seeking a priority review of their abbreviated new drug application (ANDA), prior approval supplement (PAS) or an amendment to either submission type in line with the Generic Drug U...

The European Council (EC) has approved a measure to extend the transition period for medical devices under the Medical Devices Regulation (MDR) and to remove the sell-off provisions for existing products as required under MDR and the In Vitro Diagnostic Medical Devices Regulation (IVDR).   On 7 March, the Council voted 27-0 to adopt the measure put forward by the European Parliament and Commission. The parliament voted 537-3 on 16 February to push back the MDR transiti...

Sterile drug manufacturing is a high-risk operation and to manage these risks, drug manufacturers need to “tightly control” a multitude of variables to ensure processes remain in a state of control, asserted Brooke Higgins, a senior policy advisor for global compliance in the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER).   Higgins outlined some of the consequences that can occur when these variables are not controlled, includin...

The Philippine Food and Drug Administration (FDA) has posted guidelines about relying on the decisions of other regulatory agencies to facilitate the evaluation of clinical trial applications.   FDA, which has moved to increase regulatory reliance in multiple areas in recent years, pitched the new guidance to improve access to investigational drug products for public health emergencies, rare diseases and “emerging and re-emerging infectious diseases of public health th...

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing. In Focus: US U.S. FDA extends review of BioMarin's bleeding disorder therapy ( Reuters ) California to not do business with Walgreens over abortion pills issue, Governor says ( Reuters ) WeightWatchers Moves Into the Ozempic Market With Telehealth Deal ( WSJ ) ( Reuters ) FDA panel to reevaluate the most common over-the-counter decongestant, phenylephrine, criticized as useless ( C...

"Updated on 8 March 2023 to include comments from PhRMA."   More than 10% of drugs granted accelerated approval by the US Food and Drug Administration (FDA) have not complied with the agency’s 2019 labeling guidance, according to a new study. The study authors wrote that the lack of labeling transparency can affect prescribing habits and call on FDA to ensure regulatory compliance through meetings with manufacturers, warning letters or by levying fines.   FDA’s 2...

The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) last week sent an untitled letter to Los Angeles-based Thomas Advanced Medical LLC stating that the firm’s stem cell products, which it markets for various diseases including Alzheimer’s disease and COVID-19, require regulatory approval under the agency’s regenerative medicine framework.   The untitled letter is the first sent by CBER’s bioresearch monitoring program (BIMO) ...

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing. In Focus: US Merck's drug boosts exercise capacity in pulmonary hypertension patients ( Reuters ) ( STAT ) After its drug was shown to prevent heart attacks, what’s next for Esperion? ( STAT ) ( NYTimes ) Eisai, Biogen say FDA grants priority review for Alzheimer's drug Lecanemab ( Reuters ) ( Endpoints ) Aclaris shares tank as skin disorder drug fails mid-stage study ( Reuters ) ...

Updated 7 March 2023 to clarify what products FDA's guidance on potency assays for monoclonal antibodies applies to.   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, we learned that the agency is indeed moving forward with rulemaking to get diagnostics reform, a top official involved in the Aduhelm approval story is ...

A proposed reorganization of the Food and Drug Administration Office of Regulatory Affairs (ORA) will “modify things significantly” for foods as well as medical products and is expected to be finalized this fall, said Janet Woodcock, the agency’s principal deputy commissioner at a 2 March webinar sponsored by the Alliance for a Stronger FDA.   Woodcock offered an update, yet few specifics, on the proposed restructuring of ORA, first floated on 31 January. Key among the...

The head of the US Food and Drug Administration’s (FDA) drug center said the agency has prioritized addressing the ongoing opioid pandemic over the past year to ensure drugs are used safely. In particular, the agency pointed to several initiatives such as going after online retailers selling illegal opioids and taking steps toward getting over-the-counter (OTC) naloxone to market.   On 2 March, FDA’s Center for Drug Evaluation and Research (CDER) published its annual ...

The number of US generic drug approvals rebounded in 2022 after a drop in 2021. In calendar year 2022, the US Food and Drug Administration (FDA) approved or tentatively approved 917 abbreviated new drug applications (ANDAs).   In 2021 , FDA approved or tentatively approved 776 ANDAs for generic drugs, down from 948 in 2020 and 1,014 in 2019 . The latest figures are part of FDA’s Office of Generic Drugs (OGD) 2022 Annual Report . (RELATED: Generic drug approvals ...