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Drug Safety

Pakistan Introduces Mandatory E-Reporting For Adverse Drug Reactions

Pakistan Introduces Mandatory E-Reporting For Adverse Drug Reactions

Companies submitting individual case safety reports in Pakistan will soon have to use a new e-Reporting system that is expected to simplify and streamline the submissions process.

US FDA’s Petition Procedures No Place For OTC Acetaminophen Pediatric Dosing Enforcement

US FDA’s Petition Procedures No Place For OTC Acetaminophen Pediatric Dosing Enforcement

Requests for “enforcement actions are not within the scope of FDA’s citizen petition procedures,” CDER says, rejecting petition dosing device firm Parenteral Technologies submitted as it prepares for workshop on Pediatric Research Equity Act requirements for OTC NDA sponsors.

GSK Tab To Clear Zantac Litigation Ledger Of 93% Of Complaints Pending In State Courts: $2.2Bn

GSK Tab To Clear Zantac Litigation Ledger Of 93% Of Complaints Pending In State Courts: $2.2Bn

UK pharma also reaches agreement in principle, subject to DoJ approval, to pay $70m to resolve a whistleblower complaint filed by Valisure, the testing lab which in 2019 raised concerns about a potential link between the use of drugs containing ranitidine, a histamine-2 blocker, and cancer.

FDA Workshop To Consider Pediatric Research Rules Compliance By OTCs Available Through NDAs

FDA Workshop To Consider Pediatric Research Rules Compliance By OTCs Available Through NDAs

NDAs for additional OTC products containing acetaminophen and/or NSAIDs and indicated for use by children between 2 and less than 12 years old would trigger compliance by application sponsors with the act passed in 2003 to address lack of pediatric use information in drug labeling.

Nozzle At Tip Of Problems For Florida Eye Drop Firm: US FDA Warns Of GMP, Monograph Violations

Nozzle At Tip Of Problems For Florida Eye Drop Firm: US FDA Warns Of GMP, Monograph Violations

Regenerative Processing replaces nozzle to prevent backflow for its Regener-Eyes drops but FDA warning states numerous questions about sterility at the firm’s plant and about its procedures and systems for preventing microbial contamination.

EU Launches Safety Review Of Finasteride And Dutasteride Over Suicidal Thoughts And Behavior

EU Launches Safety Review Of Finasteride And Dutasteride Over Suicidal Thoughts And Behavior

France’s regulatory agency, which triggered the review, says it believes that the addition of suicidal ideation to the product information for finasteride and reports of cases of completed suicide “seriously alter” the product’s benefit-risk profile. 

EMA Clarifies Quality And Equivalence Testing Expectations For Cutaneous Products

EMA Clarifies Quality And Equivalence Testing Expectations For Cutaneous Products

New guidance from the European Medicines Agency explains how in vitro and in vivo models may be used instead of clinical data for the purpose of establishing therapeutic equivalence in a stepwise approach.

Alkem And Torrent Defend Their Generics Over Failed Quality Test Claims

Alkem And Torrent Defend Their Generics Over Failed Quality Test Claims

Alkem and Torrent said the tested batches were not manufactured by them, as a recent CDSCO report pinned their drugs as “not of standard quality”. Meanwhile, other firms informed the agency themselves about counterfeit drugs on the market.

With FDA Hold Lifted, Avidity Works To Bring First DM1 Therapy To Market

With FDA Hold Lifted, Avidity Works To Bring First DM1 Therapy To Market

Avidity hopes to complete enrollment in mid-2025 for an ongoing Phase III trial of its antibody-oligonucleotide conjugate in myotonic dystrophy type 1, which has no approved drug therapy.

Growth Spurt: Pediatric Labeling Is On The Rise, Taxing US FDA Safety Monitoring

Growth Spurt: Pediatric Labeling Is On The Rise, Taxing US FDA Safety Monitoring

The US FDA Pediatric Advisory Committee uses web-posted reviews of “low safety risk” products to keep up with postmarketing monitoring requirements amid rising interest in pediatric development.