Devices

FDA Warns of Ventilation Failures in ButterflyBVM Resuscitators

FDA has issued an Early Alert concerning a potentially high-risk defect in Compact Medical's ButterflyBVM bag-valve-mask resuscitators that could cause inadequate ventilation, hypoxia, serious injury or death.

The agency said Compact Medical is removing certain lots of the single-use devices and requiring additional pre-use testing for others after identifying a risk that holes may develop in the devices' bellows, allowing air intended for the patient to escape.

As of 11/2, the company had reported no serious injuries or deaths associated with the problem.

ButterflyBVM devices are used for manual pulmonary resuscitation and emergency respiratory support.

AstraZeneca Petition Seeks to Block Cipla's Generic Lynparza

AstraZeneca has petitioned FDA to withhold approval of a Cipla ANDA for proposed new strengths of generic Lynparza (olaparib) tablets unless the generic company provides additional evidence addressing formulation differences, tablet size and potential medication errors. Lynparza, a PARP inhibitor approved for certain ovarian, breast, pancreatic and prostate cancers, is

Tidmarsh Sues Aurinia, Alleges Prasad Role in FDA Ouster

Former CDER director George Tidmarsh has filed a defamation lawsuit against Aurinia Pharmaceuticals and biotech investor Kevin Tang, alleging that they provided false accusations of bribery and abuse of regulatory authority to senior FDA officials a year ago, triggering his removal from the agency. The 23-page complaint (see below)

ICH M15 Model Evaluation Flexibility, Submission Requirements

Drug sponsors are not required to submit model analysis plans in advance under the new ICH M15 guideline on model-informed drug development (MIDD), and models that fail to meet predefined validation criteria are not necessarily disqualified from supporting regulatory decisions, international regulatory experts said during an 10/29 FDA-

Guangdong Bangze Medicine CGMP Violations

FDA says its review of records and products submitted by Guangdong Bangze Medicine Co., Ltd., in Guangdong Sheng, China, in response to an agency 1/20 request, determined there were significant violations of current good manufacturing practice (CGMP) regulations for finished drugs in the firm’s production of over-the-

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AstraZeneca Petition Seeks to Block Cipla's Generic Lynparza

Tidmarsh Sues Aurinia, Alleges Prasad Role in FDA Ouster

ICH M15 Model Evaluation Flexibility, Submission Requirements

Guangdong Bangze Medicine CGMP Violations