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This management report includes more than 650 items organized in three sections covering all aspects of quality manufacturing.

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Biological Risk Evaluation and Management for Medical Devices

Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

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Expert Committee Supports Celltrion’s Proposed Rituxan Biosimilar

October 18, 2018

Committee chairperson Brian Rini said the clinical data supported efficacy in terms of response rate, and that any discrepancies in the safety data were likely simply “what you get when you have a lower number of patients treated in this type of development program.” Read More

FDA Advisory Committee Nixes Trevena’s Opioid in Tight Vote

October 18, 2018

The FDA concluded there was insufficient evidence for a safety advantage compared to morphine. Read More

Minnesota Sues Drugmakers for Insulin Price Hikes

October 17, 2018

Minnesota is suing Novo Nordisk, Eli Lilly and Sanofi for allegedly setting artificially high prices for insulin products and then offering rebates to reap insurer contracts. Read More

PhRMA Updates TV Ad Guidelines Ahead of Mandatory DTC Price Disclosure

October 17, 2018

PhRMA released new guidelines this week on price transparency in advertising in an effort to preempt tough mandatory regulations released Monday that would require ads to include featured drugs list prices. Read More

China Approves 17 Cancer Drugs for National Health Insurer

October 17, 2018

Novartis is the best-represented drugmaker on the list, with four drugs. Read More

Judge Dismisses Lawsuit Seeking to Hold Opioid Makers Liable as Drug Dealers

October 17, 2018

The lawsuit sought to hold the drugmakers liable under the state’s Drug Dealer Liability Act (DDLA), which allows parents, employers, insurers and government entities to sue “persons in the community who have joined the illegal drug market.” Read More

Miami Pharmacy Owner Admits to Submitting Over $8 Million in Fraudulent Medicare Claims

October 17, 2018

The plea followed an investigation by the Justice Department’s Medicare Fraud Strike Force. Read More

Boehringer Wins Third Bellwether Suit Over its Blood Thinner

October 17, 2018

The plaintiff alleged that the drugmaker didn’t sufficiently warn physicians about the drug’s potential risks. Read More

Illinois Public Employee Risk Pools Sue Opioid Makers, Distributors

October 16, 2018

Two Illinois employee risk pools have become the first institutions of their kind in the state to sue opioid manufacturers and distributors. Read More

Apotex Hits Timing Snag Over 180-Day Exclusivity for Competitive Generic Therapy

October 16, 2018

The FDA denied a request by Canadian drugmaker Apotex to rescind its approval of a competing ANDA for a potassium chloride oral solution submitted by Novel Laboratories — granted on the same day Apotex qualified for 180-day competitive generic therapy (CGT) exclusivity. Read More

FDA Makes Suggestions for Improving Consumer Comprehension of Statistics in DTC Ads

October 16, 2018

On the heels of CMS’ proposed rule to require disclosure of drug prices in TV ads, the FDA issued draft guidance Tuesday on presenting efficacy and risk information in direct-to-consumer (DTC) promotional materials and drug ads. Read More

EMA Pursues Common Data Model for Europe

October 16, 2018

“Each CDM system represents a trade off on where to set the balance between the efforts invested in data management and data analysis. Where the emphasis is placed is likely to have an impact on the speed of studies,” the EMA said. Read More

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Regulatory Affairs
RSS

Expert Committee Supports Celltrion’s Proposed Rituxan Biosimilar

FDA Advisory Committee Nixes Trevena’s Opioid in Tight Vote

Minnesota Sues Drugmakers for Insulin Price Hikes

PhRMA Updates TV Ad Guidelines Ahead of Mandatory DTC Price Disclosure

China Approves 17 Cancer Drugs for National Health Insurer

Judge Dismisses Lawsuit Seeking to Hold Opioid Makers Liable as Drug Dealers

Miami Pharmacy Owner Admits to Submitting Over $8 Million in Fraudulent Medicare Claims

Boehringer Wins Third Bellwether Suit Over its Blood Thinner

Illinois Public Employee Risk Pools Sue Opioid Makers, Distributors

Apotex Hits Timing Snag Over 180-Day Exclusivity for Competitive Generic Therapy

FDA Makes Suggestions for Improving Consumer Comprehension of Statistics in DTC Ads

EMA Pursues Common Data Model for Europe

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